Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 68071-3447
- 11-digit product format
- 680713447
- Labeler code
- 68071
- Product ID
- 68071-3447_2d67b889-65d1-1c00-e063-6394a90a3d24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA210211
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| NO70W886KK | HYDROCODONE BITARTRATE | 34195-34-1 | HYDROCODONE BITARTRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3447-3 | 68071344703 | 30 TABLET in 1 BOTTLE (68071-3447-3) | 30 tablet | 2023-06-23 | No | No | Historical |