Medicine
Apadaz 325 mg/8.16 mg tablet
Apadaz 325 mg/8.16 mg tablet is a prescription medicine containing Acetaminophen and Benzhydrocodone for oral use, marketed by Zevra Therapeutics, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Acetaminophen and Benzhydrocodone
- Brand
- Apadaz
- Strength
- 325 mg/8.16 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets
- Marketing authorisation holder
- Zevra Therapeutics
- Manufacturer
- Zevra Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). Store APADAZ securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 February 2018
- Identifiers
- RxCUI 2001358, 2001364, 2118728 +3DailyMed set ID 0590d4e5-7107-4015-a6a8-deac14265aa2NDC 70040-0189Application NDA208653
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle, plastic | 70040-0189-1 | Zevra Therapeutics | 23 February 2018 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 23 February 2018 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Acetaminophen and Benzhydrocodone
Clinical summary
Acetaminophen and Benzhydrocodone is a fixed-dose combination medicine 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. MedsAcross supplies Acetaminophen and Benzhydrocodone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Acetaminophen and BenzhydrocodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- APADAZ prescribing information (Zevra Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Apadaz 325 mg/8.16 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.