OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 87063-032
- 11-digit product format
- 870630032
- Labeler code
- 87063
- Product ID
- 87063-032_44677216-216d-f82c-e063-6294a90a3dca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA207510
- Marketing category
- ANDA
- Marketing start
- 2019-06-01
- 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
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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C, 362O9ITL9D |
| Rxcui | 1049214, 1049221, 1049225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87063-032-01 | OXYCODONE AND ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 87063-032-05 | OXYCODONE AND ACETAMINOPHEN | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 87063-032-10 | OXYCODONE AND ACETAMINOPHEN | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 87063-032-20 | OXYCODONE AND ACETAMINOPHEN | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
| 87063-032-30 | OXYCODONE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 87063-032-60 | OXYCODONE AND ACETAMINOPHEN | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 87063-032-90 | OXYCODONE AND ACETAMINOPHEN | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87063-032-01 | 87063003201 | 100 TABLET in 1 BOTTLE (87063-032-01) | 100 tablet | 2025-11-25 | No | No | Current |
| 87063-032-05 | 87063003205 | 500 TABLET in 1 BOTTLE (87063-032-05) | 500 tablet | 2025-11-25 | No | No | Current |
| 87063-032-10 | 87063003210 | 10 TABLET in 1 BOTTLE (87063-032-10) | 10 tablet | 2025-11-25 | No | No | Current |
| 87063-032-20 | 87063003220 | 20 TABLET in 1 BOTTLE (87063-032-20) | 20 tablet | 2025-11-25 | No | No | Current |
| 87063-032-30 | 87063003230 | 30 TABLET in 1 BOTTLE (87063-032-30) | 30 tablet | 2025-11-25 | No | No | Current |
| 87063-032-60 | 87063003260 | 60 TABLET in 1 BOTTLE (87063-032-60) | 60 tablet | 2025-11-25 | No | No | Current |
| 87063-032-90 | 87063003290 | 90 TABLET in 1 BOTTLE (87063-032-90) | 90 tablet | 2025-11-25 | No | No | Current |