Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0904-6421
- 11-digit product format
- 009046421
- Labeler code
- 0904
- Product ID
- 0904-6421_24c08ad8-be13-44d0-ad85-169db27d9b8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA040148
- Marketing category
- ANDA
- Marketing start
- 2013-03-07
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6421-61 | 00904642161 | 100 BLISTER PACK in 1 CARTON (0904-6421-61) > 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2013-03-07 | 0000-00-00 | No | No | Current |