Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0591-2175
- 11-digit product format
- 005912175
- Labeler code
- 0591
- Product ID
- 0591-2175_7b5d1dc8-3255-426b-b153-01e741c57a09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA206470
- Marketing category
- ANDA
- Marketing start
- 2016-07-28
- Marketing end
- 2019-10-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record