OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 72189-255
- 11-digit product format
- 721890255
- Labeler code
- 72189
- Product ID
- 72189-255_36d68732-0635-1380-e063-6394a90a69c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA207510
- Marketing category
- ANDA
- Marketing start
- 2021-08-10
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 10 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 |
|---|
| 72189-255-30 | 72189025530 | 30 TABLET in 1 BOTTLE (72189-255-30) | 30 tablet | 2021-08-10 | No | No | Historical |
| 72189-255-60 | 72189025560 | 60 TABLET in 1 BOTTLE (72189-255-60) | 60 tablet | 2021-08-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| OXYCODONE | DIRECT RX | 2025-06-05 | HUMAN PRESCRIPTION DRUG LABEL | 10 |