OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 76420-321
- 11-digit product format
- 764200321
- Labeler code
- 76420
- Product ID
- 76420-321_32cd8c6c-83cf-fa16-e063-6394a90a6f38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA207419
- Marketing category
- ANDA
- Marketing start
- 2017-04-11
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- 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 |
| C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE | 124-90-3 | OXYCODONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-321-01 | 76420032101 | 100 TABLET in 1 BOTTLE (76420-321-01) | 100 tablet | 2025-04-15 | No | No | Historical |
| 76420-321-05 | 76420032105 | 500 TABLET in 1 BOTTLE (76420-321-05) | 500 tablet | 2025-04-15 | No | No | Historical |
| 76420-321-30 | 76420032130 | 30 TABLET in 1 BOTTLE (76420-321-30) | 30 tablet | 2025-04-15 | No | No | Historical |
| 76420-321-60 | 76420032160 | 60 TABLET in 1 BOTTLE (76420-321-60) | 60 tablet | 2025-04-15 | No | No | Historical |
| 76420-321-90 | 76420032190 | 90 TABLET in 1 BOTTLE (76420-321-90) | 90 tablet | 2025-04-15 | No | No | Historical |