Oxycodone and Acetaminophen
- Product NDC
- 63629-9501
- 11-digit product format
- 636299501
- Labeler code
- 63629
- Product ID
- 63629-9501_19b90613-9188-4315-a65e-2c4f95323860
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201278
- Marketing category
- ANDA
- Marketing start
- 2014-08-28
- 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
- 2027-12-31
- 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 |
|---|
| 63629-9501-1 | 63629950101 | 500 TABLET in 1 BOTTLE, PLASTIC (63629-9501-1) | 500 tablet | 2022-12-14 | No | No | Historical |