HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 82804-116
- 11-digit product format
- 828040116
- Labeler code
- 82804
- Product ID
- 82804-116_9bad45b7-32ce-47aa-bfdf-8e6a75513056
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040409
- Marketing category
- ANDA
- Marketing start
- 2000-10-20
- 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 |
|---|
| 82804-116-12 | 82804011612 | 12 TABLET in 1 BOTTLE (82804-116-12) | 12 tablet | 2024-07-02 | No | No | Historical |