Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 42291-333
- 11-digit product format
- 422910333
- Labeler code
- 42291
- Product ID
- 42291-333_638c8369-e57e-cbb0-e053-2991aa0a0be2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE, Inc.
- Application
- ANDA040746
- Marketing category
- ANDA
- Marketing start
- 2016-09-06
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record