Oxycodone and Acetaminophen
- Product NDC
- 71335-1953
- 11-digit product format
- 713351953
- Labeler code
- 71335
- Product ID
- 71335-1953_1858e9af-6a66-478e-8db0-0723f439f7bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207419
- Marketing category
- ANDA
- Marketing start
- 2017-04-11
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 7.5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049225 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1953-0 | 71335195300 | 84 TABLET in 1 BOTTLE (71335-1953-0) | 84 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |
| 71335-1953-1 | 71335195301 | 120 TABLET in 1 BOTTLE (71335-1953-1) | 120 tablet | 2021-09-29 | 0000-00-00 | No | No | Current |
| 71335-1953-2 | 71335195302 | 90 TABLET in 1 BOTTLE (71335-1953-2) | 90 tablet | 2021-09-29 | 0000-00-00 | No | No | Current |
| 71335-1953-3 | 71335195303 | 60 TABLET in 1 BOTTLE (71335-1953-3) | 60 tablet | 2021-09-17 | 0000-00-00 | No | No | Current |
| 71335-1953-4 | 71335195304 | 30 TABLET in 1 BOTTLE (71335-1953-4) | 30 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 71335-1953-5 | 71335195305 | 100 TABLET in 1 BOTTLE (71335-1953-5) | 100 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |
| 71335-1953-6 | 71335195306 | 45 TABLET in 1 BOTTLE (71335-1953-6) | 45 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |
| 71335-1953-7 | 71335195307 | 28 TABLET in 1 BOTTLE (71335-1953-7) | 28 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |
| 71335-1953-8 | 71335195308 | 168 TABLET in 1 BOTTLE (71335-1953-8) | 168 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |
| 71335-1953-9 | 71335195309 | 20 TABLET in 1 BOTTLE (71335-1953-9) | 20 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |