Prescription medicine
Acetaminophen and benzhydrocodone Brand names: Apadaz
Acetaminophen and benzhydrocodone (Apadaz) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the acetaminophen and benzhydrocodone FDA label on DailyMed (effective January 7, 2025, Zevra Therapeutics, Inc.); the NDA 208653 record on Drugs@FDA; every acetaminophen and benzhydrocodone label on DailyMed.
Highlights of the record
FDA label of January 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF APADAZ.
Addiction, Abuse, and Misuse Because the use of APADAZ 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 APADAZ, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of APADAZ are essential [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of APADAZ, 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 usageAPADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 4.08 mg / 325 mg
- 6.12 mg / 325 mg
- 8.16 mg / 325 mg
Tablet.
On the market
- Earliest approval on file
- February 23, 2018 Apadaz, Zevra Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 22, 2031 Apadaz tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest December 18, 2020
- FAERS reports
- 19 through July 30, 2026
What is acetaminophen and benzhydrocodone used for?
From the label: indications and usageAPADAZ is indicated for the short-term (no more than 14 days) management of acute 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, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 ) ] reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. […]
Conditions named in the indications of acetaminophen and benzhydrocodone's FDA labels, with every medicine labeled for each:
Source: FDA drug label (APADAZ), Zevra Therapeutics, Inc., effective January 7, 2025 (SPL set 0590d4e5-7107-4015-a6a8-deac14265aa2), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and benzhydrocodone (Apadaz)?
No generic acetaminophen and benzhydrocodone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Apadaz tablets: the compound patent runs to February 22, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has acetaminophen and benzhydrocodone been recalled?
The FDA's Enforcement Report lists 1 recall naming acetaminophen and benzhydrocodone since 2020: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 18, 2020 | Class III | KVK-Tech, Inc. | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetaminophen and benzhydrocodone label say about other medicines?
The acetaminophen and benzhydrocodone label names 20 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 | drug interactions | Clinical Impact: May reduce the analgesic effect of APADAZ 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 APADAZ 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 APADAZ 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. Rifampin, carbamazepine, phenytoin etc. Benzodiazepines and Other Central Nervous System (CNS) Depressants |
| 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 (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid … |
| Erythromycin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of APADAZ 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. … Intervention: If concomitant use is necessary, consider increasing the APADAZ dosage until stable drug effects are achieved [see Dosage and Administration ( 2 )]. Assess for signs of opioid withdrawal. … |
| Hydrocodone | boxed warning | Accidental Ingestion Accidental ingestion of even one dose of APADAZ, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions ( 5.2 )]. |
| Ketoconazole | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of APADAZ 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. … Intervention: If concomitant use is necessary, consider increasing the APADAZ dosage until stable drug effects are achieved [see Dosage and Administration ( 2 )]. Assess for signs of opioid withdrawal. … |
| 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 (MAO) 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. … |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of APADAZ and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Naloxone | 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, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death. … (including sedation). If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (), Warnings and Precautions (,,)]. … |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and … Intervention: The use of APADAZ is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
Every other medicine the acetaminophen and benzhydrocodone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of APADAZ 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. … for signs of respiratory depression and sedation. Rifampin, carbamazepine, phenytoin etc. Benzodiazepines and Other Central Nervous System (CNS) Depressants |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of APADAZ 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. … patients at frequent intervals for signs of respiratory depression and sedation. Rifampin, carbamazepine, phenytoin etc. Benzodiazepines and Other Central Nervous System (CNS) Depressants |
| Ritonavir | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of APADAZ 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. … Intervention: If concomitant use is necessary, consider increasing the APADAZ dosage until stable drug effects are achieved [see Dosage and Administration ( 2 )]. Assess for signs of opioid withdrawal. … |
| 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 (MAO) 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 (…). If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and … Intervention: The use of APADAZ 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 (MAO) inhibitors (those intended to treat … |
Check acetaminophen and benzhydrocodone against other medicines
Source: FDA drug label (APADAZ), Zevra Therapeutics, Inc., effective January 7, 2025 (SPL set 0590d4e5-7107-4015-a6a8-deac14265aa2), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen and benzhydrocodone?
The FDA Adverse Event Reporting System holds 19 reports that list acetaminophen and benzhydrocodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 6 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.
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 benzhydrocodone?
27 other medicines are given the same way (oral) and in the same FDA class as acetaminophen and benzhydrocodone 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 |
|---|---|---|---|---|
| Aspirin | Pain | none listed | $0.0142 per tablet 81 mg tablet | A presentation being discontinued |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| 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 |
| Phenazopyridine | Pain | none listed | $0.154 per tablet 100 mg tablet | No current entry |
| Etodolac | Pain | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Ketorolac | Pain | 33 labelers | $0.164 per tablet 10 mg tablet | In shortage |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Acetaminophen and benzhydrocodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other