Oxycodone and Acetaminophen
- Product NDC
- 63187-823
- 11-digit product format
- 631870823
- Labeler code
- 63187
- Product ID
- 63187-823_bd442a36-9c53-4088-bc80-749efcfa0bc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201972
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- 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 |
|---|
| 63187-823-15 | 63187082315 | 15 TABLET in 1 BOTTLE (63187-823-15) | 15 tablet | 2016-12-01 | No | No | Historical |
| 63187-823-20 | 63187082320 | 20 TABLET in 1 BOTTLE (63187-823-20) | 20 tablet | 2016-12-01 | No | No | Historical |
| 63187-823-30 | 63187082330 | 30 TABLET in 1 BOTTLE (63187-823-30) | 30 tablet | 2016-12-01 | No | No | Historical |
| 63187-823-60 | 63187082360 | 60 TABLET in 1 BOTTLE (63187-823-60) | 60 tablet | 2016-12-01 | No | No | Historical |
| 63187-823-90 | 63187082390 | 90 TABLET in 1 BOTTLE (63187-823-90) | 90 tablet | 2017-03-01 | No | No | Historical |