Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 76420-133
- 11-digit product format
- 764200133
- Labeler code
- 76420
- Product ID
- 76420-133_43413993-4070-bd37-e063-6294a90ac4a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA202991
- Marketing category
- ANDA
- Marketing start
- 2016-04-12
- 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 |
|---|
| 76420-133-01 | 76420013301 | 100 TABLET in 1 BOTTLE (76420-133-01) | 100 tablet | 2025-11-10 | No | No | Historical |
| 76420-133-05 | 76420013305 | 500 TABLET in 1 BOTTLE (76420-133-05) | 500 tablet | 2025-11-10 | No | No | Historical |
| 76420-133-30 | 76420013330 | 30 TABLET in 1 BOTTLE (76420-133-30) | 30 tablet | 2020-12-16 | No | No | Historical |
| 76420-133-60 | 76420013360 | 60 TABLET in 1 BOTTLE (76420-133-60) | 60 tablet | 2025-11-10 | No | No | Historical |
| 76420-133-90 | 76420013390 | 90 TABLET in 1 BOTTLE (76420-133-90) | 90 tablet | 2025-11-10 | No | No | Historical |