Oxycodone and Acetaminophen
- Product NDC
- 63187-984
- 11-digit product format
- 631870984
- Labeler code
- 63187
- Product ID
- 63187-984_09fe7043-1a50-4d4a-89ff-e0acc2850023
- 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
- 2013-07-15
- 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 |
|---|
| 63187-984-10 | 63187098410 | 10 TABLET in 1 BOTTLE (63187-984-10) | 10 tablet | 2018-02-01 | No | No | Historical |
| 63187-984-12 | 63187098412 | 12 TABLET in 1 BOTTLE (63187-984-12) | 12 tablet | 2018-02-01 | No | No | Historical |
| 63187-984-15 | 63187098415 | 15 TABLET in 1 BOTTLE (63187-984-15) | 15 tablet | 2018-02-01 | No | No | Historical |
| 63187-984-30 | 63187098430 | 30 TABLET in 1 BOTTLE (63187-984-30) | 30 tablet | 2018-02-01 | No | No | Historical |
| 63187-984-60 | 63187098460 | 60 TABLET in 1 BOTTLE (63187-984-60) | 60 tablet | 2018-02-01 | No | No | Historical |