HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 82804-003
- 11-digit product format
- 828040003
- Labeler code
- 82804
- Product ID
- 82804-003_62dd3c7a-4150-44a2-b05b-bc31308f2200
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040400
- Marketing category
- ANDA
- Marketing start
- 2000-07-26
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 10 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 |
|---|
| 82804-003-30 | 82804000330 | 30 TABLET in 1 BOTTLE (82804-003-30) | 30 tablet | 2023-08-28 | No | No | Historical |
| 82804-003-60 | 82804000360 | 60 TABLET in 1 BOTTLE (82804-003-60) | 60 tablet | 2023-08-28 | No | No | Historical |
| 82804-003-90 | 82804000390 | 90 TABLET in 1 BOTTLE (82804-003-90) | 90 tablet | 2023-08-28 | No | No | Historical |