Quick answers
- What is Benzhydrocodone and acetaminophen used for?
- The FDA-approved label (Apadaz, Zevra Therapeutics, Inc., January 7, 2025) says: “APADAZ 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 […] reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Benzhydrocodone and acetaminophen have a boxed warning?
- Yes. The FDA label for Apadaz has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF APADAZ”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Benzhydrocodone and acetaminophen?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Benzhydrocodone and acetaminophen been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Benzhydrocodone and acetaminophen?
- 1 company lists prescription products of Benzhydrocodone and acetaminophen in the FDA NDC Directory, including Zevra Therapeutics, Inc..
What Benzhydrocodone and acetaminophen is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
APADAZ 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 […] reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid …
— FDA label: Apadaz, Zevra Therapeutics, Inc., effective January 7, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF APADAZ
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Apadaz |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Zevra Therapeutics, Inc.3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208653 APADAZ | Zevra Therap | February 23, 2018 | 6, latest October 31, 2024 2024: REMS · 2023: Labeling · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Apadaz, Zevra Therapeutics, Inc., effective January 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →