Prescription medicine
Acetaminophen and hydrocodone Brand names: Norco
Acetaminophen and hydrocodone (Norco) is a prescription medicine. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.152 per hydrocodone-acetaminophen 10-325 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the acetaminophen and hydrocodone FDA label on DailyMed (effective October 23, 2025, Elite Laboratories, Inc.); every acetaminophen and hydrocodone label on DailyMed.
Highlights of the record
FDA label of October 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS..
Addiction, Abuse, and Misuse Because the use of hydrocodone bitartrate and acetaminophen tablets 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 ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydrocodone bitartrate and acetaminophen tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone [see WARNINGS ]. 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 usageHydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 2.5 mg / 325 mg
- 2.5 mg/5ml / 108 mg/5ml
- 5 mg / 325 mg
- 5 mg / 300 mg
- 5 mg/10ml / 217 mg/10ml
- 7.5 mg / 325 mg
- 7.5 mg / 300 mg
- 7.5 mg/15ml / 325 mg/15ml
- 10 mg / 325 mg
- 10 mg / 300 mg
- 10 mg/15ml / 300 mg/15ml
- 325 mg / 10 mg
Tablet; solution; liquid.
On the market
- Generic approvals
- 144 first May 3, 1982; 26 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 36 of which 36 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.152 per tablet Hydrocodone-acetaminophen 10-325 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 14 since 2012 4 Class I among all firms' recalls; latest November 19, 2021
- FAERS reports
- 56,022 through July 30, 2026
What is acetaminophen and hydrocodone used for?
From the label: indications and usageHydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 ], reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Conditions named in the indications of acetaminophen and hydrocodone's FDA labels, with every medicine labeled for each:
From other acetaminophen and hydrocodone labelsPain: INDICATIONS & USAGE Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Hydrocodone Bitartrate and Acetaminophen), Elite Laboratories, Inc., effective October 23, 2025 (SPL set 89b8145f-5310-4b58-a65d-586dc90d642d), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and hydrocodone (Norco)?
The FDA approved the first generic acetaminophen and hydrocodone on May 3, 1982. 144 generic applications are approved; 26 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acetaminophen and hydrocodone from 36 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen and hydrocodone (Norco)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.152 per Hydrocodone-acetaminophen 10-325 mg tablet, down 4% from $0.158 on October 8, 2025. 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-acetaminophen 10-325 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrocodone-acetaminophen 10-300 mg tablet | Generic | $0.247 per tablet | $7.40 | -0.7% |
| Hydrocodone-acetaminophen 10-325 mg tablet | Generic | $0.152 per tablet | $4.57 | -4% |
| Hydrocodone-acetaminophen 5-300 mg tablet | Generic | $0.175 per tablet | $5.26 | +2% |
| Hydrocodone-acetaminophen 5-325 mg tablet | Generic | $0.136 per tablet | $4.08 | +7% |
| Hydrocodone-acetaminophen 7.5-300 mg tablet | Generic | $0.214 per tablet | $6.41 | +3% |
| Hydrocodone-acetaminophen 7.5-325 mg tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Hydrocodone-acetaminophen 7.5-325 mg/15 mL solution | Generic | $0.245 per mL | n/a | +13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetaminophen and hydrocodone been recalled?
The FDA's Enforcement Report lists 14 recalls naming acetaminophen and hydrocodone since 2012: 4 Class I (the most serious), 6 Class II, 4 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 19, 2021 | Class II | Ascent Pharmaceuticals, Inc. | Product Mix-up |
| October 26, 2020 | Class II | Ascent Pharmaceuticals, Inc. | Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP … |
| May 24, 2018 | Class III | LUPIN SOMERSET | Labeling: Missing Label |
| August 17, 2017 | Class III | VistaPharm, Inc. | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance |
| January 18, 2017 | Class II | VistaPharm, Inc. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. |
| January 15, 2014 | Class II | Watson Laboratories Inc | Failed Tablet/Capsule Specifications; Product contains broken tablets. |
| August 30, 2013 | Class III | Watson Laboratories Inc | Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetaminophen and hydrocodone label say about other medicines?
The acetaminophen and hydrocodone label names 22 other medicines in its interaction, contraindication or warning sections. 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 | warnings | Additionally, avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including hydrocodone bitartrate and acetaminophen tablets. |
| Butorphanol | drug interactions | Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of hydrocodone bitartrate and acetaminophen tablets and/or precipitate withdrawal symptoms. |
| Carbamazepine | drug interactions | Inducers of CYP3A4 The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone bitartrate and acetaminophen tablets [see CLINICAL PHARMACOLOGY ], resulting in decreased efficacy or … |
| Cyclobenzaprine | drug interactions | … serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin … |
| Erythromycin | drug interactions | Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. … |
| Gabapentin | drug interactions | … other sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Ketoconazole | drug interactions | Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. … |
| Linezolid | drug interactions | … monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS ; |
| Metaxalone | drug interactions | … neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome … |
| Methylene blue | drug interactions | … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS ; |
| Mirtazapine | drug interactions | … (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Nalbuphine | drug interactions | Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of hydrocodone bitartrate and acetaminophen tablets and/or precipitate withdrawal symptoms. |
| Nalmefene | warnings | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | warnings | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
Every other medicine the acetaminophen and hydrocodone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome, or opioid toxicity (e.g. … |
| Phenytoin | drug interactions | Inducers of CYP3A4 The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration … |
| Pregabalin | drug interactions | … general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation … |
| Rifampin | drug interactions | Inducers of CYP3A4 The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration … |
| Ritonavir | drug interactions | … azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of the hydrocodone from hydrocodone bitartrate and acetaminophen tablets … |
| Tramadol | drug interactions | … the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome, or opioid toxicity (e.g. … |
| Trazodone | drug interactions | … that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those … |
Source: FDA drug label (Hydrocodone Bitartrate and Acetaminophen), Elite Laboratories, Inc., effective October 23, 2025 (SPL set 89b8145f-5310-4b58-a65d-586dc90d642d), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen and hydrocodone?
The FDA Adverse Event Reporting System holds 56,022 reports that list acetaminophen and hydrocodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8,227 are coded as a death and 7,199 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 2021 (19,947, against a median of 2,147 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 acetaminophen and hydrocodone?
27 other medicines are given the same way (oral) and in the same FDA class as acetaminophen and 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 |
| 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 |
| 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 |
| Tapentadol | Pain | 4 labelers | $14.48 per tablet 100 mg tablet | No current entry |
| Levorphanol | Pain | 7 labelers | $10.65 per tablet 2 mg tablet | No current entry |
Every medicine labeled for the same conditions as acetaminophen and hydrocodone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does acetaminophen and hydrocodone compare with medicines for the same use?
2 side-by-side pages set acetaminophen and hydrocodone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to acetaminophen and hydrocodone
- 27 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Acetaminophen and hydrocodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other