Oxycodone and Acetaminophen
- Product NDC
- 71205-347
- 11-digit product format
- 712050347
- Labeler code
- 71205
- Product ID
- 71205-347_b53c68fe-b3a3-4a62-b75b-cb831ef1a81f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207419
- Marketing category
- ANDA
- Marketing start
- 2017-04-11
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Oxycodone and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049214 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-347-12 | 71205034712 | 12 TABLET in 1 BOTTLE (71205-347-12) | 12 tablet | 2019-11-01 | 0000-00-00 | No | No | Current |
| 71205-347-15 | 71205034715 | 15 TABLET in 1 BOTTLE (71205-347-15) | 15 tablet | 2019-11-01 | 0000-00-00 | No | No | Current |
| 71205-347-20 | 71205034720 | 20 TABLET in 1 BOTTLE (71205-347-20) | 20 tablet | 2019-11-01 | 0000-00-00 | No | No | Current |
| 71205-347-30 | 71205034730 | 30 TABLET in 1 BOTTLE (71205-347-30) | 30 tablet | 2019-11-01 | 0000-00-00 | No | No | Current |
| 71205-347-60 | 71205034760 | 60 TABLET in 1 BOTTLE (71205-347-60) | 60 tablet | 2019-11-01 | 0000-00-00 | No | No | Current |
| 71205-347-90 | 71205034790 | 90 TABLET in 1 BOTTLE (71205-347-90) | 90 tablet | 2019-11-01 | 0000-00-00 | No | No | Current |