Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0904-6824
- 11-digit product format
- 009046824
- Labeler code
- 0904
- Product ID
- 0904-6824_0671ed02-4c4c-4403-b616-3dd8fbdd052b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA206245
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 0904-6824-45 | 00904682445 | 80 BLISTER PACK in 1 CARTON (0904-6824-45) > 1 TABLET in 1 BLISTER PACK | 80 blister pack | 2016-12-01 | 0000-00-00 | No | No | Current |
| 0904-6824-61 | 00904682461 | 100 BLISTER PACK in 1 CARTON (0904-6824-61) > 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2016-12-01 | 0000-00-00 | No | No | Current |