Prescription medicine
Hydrocodone Brand names: Hysingla; first approved as Zohydro Er
Hydrocodone (Hysingla) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $7.95 per hydrocodone ER 15 mg capsule in the October 7, 2026 NADAC survey; its other strengths are brand-only, $13.31 per Hysingla ER 20 mg tablet.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the hydrocodone FDA label on DailyMed (effective May 29, 2026); the NDA 202880 record on Drugs@FDA; every hydrocodone label on DailyMed.
Highlights of the record
FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYSINGLA ER.
Addiction, Abuse, and Misuse Because the use of HYSINGLA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of HYSINGLA ER, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of HYSINGLA ER are essential. Instruct patients to swallow HYSINGLA ER tablets whole; crushing, chewing, or dissolving HYSINGLA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of HYSINGLA ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2) ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]
Used for
From the label: indications and usageHYSINGLA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
Forms and strengths
- 10 mg
- 15 mg
- 20 mg
- 30 mg
- 40 mg
- 50 mg
- 60 mg
- 80 mg
- 100 mg
- 120 mg
Extended-release tablet; extended-release capsule.
On the market
- Earliest approval on file
- October 25, 2013 Zohydro Er, Recro Gainesville; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first January 21, 2020; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 21, 2031 Hysingla ER tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $7.95 per capsule Hydrocodone ER 15 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 43,191 through July 30, 2026
What is hydrocodone used for?
From the label: indications and usageHYSINGLA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve opioid analgesics, including HYSINGLA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. HYSINGLA ER is not indicated as an as-needed (prn) analgesic. […]
Conditions named in the indications of hydrocodone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Hysingla ER), Knoa Pharma LLC, effective May 29, 2026 (SPL set b7d23ac2-e776-9f62-3290-c64c2d6eb353), via openFDA; the full label on DailyMed
Is there a generic for hydrocodone (Hysingla)?
The FDA approved the first generic hydrocodone on January 21, 2020. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists hydrocodone from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 19 patents for Hysingla ER tablets, the last expiring on December 21, 2031; a patent listed only for Zohydro ER capsules runs to September 12, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2020 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydrocodone (Hysingla)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.95 per Hydrocodone ER 15 mg capsule, up 34% from $5.94 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydrocodone ER 15 mg capsule (generic)
- Hysingla ER 20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrocodone ER 15 mg capsule | Generic | $7.95 per capsule | $238.41 | +34% |
| Hysingla ER 20 mg tablet | Brand | $13.31 per tablet | $399.22 | +9% |
| Hysingla ER 30 mg tablet | Brand | $19.36 per tablet | $580.95 | +8% |
| Hysingla ER 40 mg tablet | Brand | $26.16 per tablet | $784.84 | +9% |
| Hysingla ER 60 mg tablet | Brand | $36.17 per tablet | $1,085.24 | +8% |
| Hysingla ER 80 mg tablet | Brand | $48.66 per tablet | $1,459.65 | +8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the hydrocodone label say about other medicines?
The hydrocodone label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name hydrocodone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of HYSINGLA ER and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of HYSINGLA ER and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Carbamazepine | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inducers can decrease the plasma concentration of hydrocodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone. … intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Erythromycin | drug interactions | Clinically Significant Drug Interactions with HYSINGLA ER Inhibitors of CYP3A4 Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. … Assess for signs of opioid withdrawal. Examples Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Gabapentin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Ketoconazole | drug interactions | Clinically Significant Drug Interactions with HYSINGLA ER Inhibitors of CYP3A4 Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. … Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Lactulose | drug interactions | Strong Laxatives Clinical Impact: Concomitant use of HYSINGLA ER with strong laxatives that rapidly increase gastrointestinal motility, may decrease hydrocodone absorption and result in decreased hydrocodone plasma levels. Intervention: If HYSINGLA ER is used in these patients, regularly evaluate for the development of adverse events as well as changing analgesic requirements. Example: lactulose |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended … |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of HYSINGLA ER and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
Every other medicine the hydrocodone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Naloxone | warnings and precautions | Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of HYSINGLA ER is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: Phenelzine, tranylcypromine, linezolid |
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inducers can decrease the plasma concentration of hydrocodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone. … of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Pregabalin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inducers can decrease the plasma concentration of hydrocodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone. … frequent intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | Clinically Significant Drug Interactions with HYSINGLA ER Inhibitors of CYP3A4 Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. … azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of HYSINGLA ER is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: Phenelzine, tranylcypromine, linezolid |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat … |
Other labels that name hydrocodone
Source: FDA drug label (Hysingla ER), Knoa Pharma LLC, effective May 29, 2026 (SPL set b7d23ac2-e776-9f62-3290-c64c2d6eb353), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrocodone?
The FDA Adverse Event Reporting System holds 43,191 reports that list hydrocodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 21,422 are coded as a death and 4,422 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (21,042, against a median of 918 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as hydrocodone?
34 other medicines are given the same way (oral) and in the same FDA class as hydrocodone or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as hydrocodone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does hydrocodone compare with medicines for the same use?
13 side-by-side pages set hydrocodone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to hydrocodone
- 34 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Hydrocodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other