OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 63629-8888
- 11-digit product format
- 636298888
- Labeler code
- 63629
- Product ID
- 63629-8888_46b8552e-51a2-4167-8d21-4e5d4feee8da
- 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; 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 | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049221 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8888-1 | OXYCODONE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | | 104 |
| 63629-8888-2 | OXYCODONE AND ACETAMINOPHEN | 12 in 1 BOTTLE | TABLET | 12 | | 104 |
| 63629-8888-3 | OXYCODONE AND ACETAMINOPHEN | 40 in 1 BOTTLE | TABLET | 40 | | 104 |
| 63629-8888-4 | OXYCODONE AND ACETAMINOPHEN | 60 in 1 BOTTLE | TABLET | 60 | | 104 |
| 63629-8888-5 | OXYCODONE AND ACETAMINOPHEN | 90 in 1 BOTTLE | TABLET | 90 | | 104 |
| 63629-8888-6 | OXYCODONE AND ACETAMINOPHEN | 120 in 1 BOTTLE | TABLET | 120 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8888 | OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 6 package rows | 20240602_3791abd3-fcdf-4c8d-b46d-db6e5c805770.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8888-1 | 63629888801 | 30 TABLET in 1 BOTTLE (63629-8888-1) | 30 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 63629-8888-2 | 63629888802 | 12 TABLET in 1 BOTTLE (63629-8888-2) | 12 tablet | 2023-03-15 | 0000-00-00 | No | No | Current |
| 63629-8888-3 | 63629888803 | 40 TABLET in 1 BOTTLE (63629-8888-3) | 40 tablet | 2023-03-15 | 0000-00-00 | No | No | Current |
| 63629-8888-4 | 63629888804 | 60 TABLET in 1 BOTTLE (63629-8888-4) | 60 tablet | 2021-10-26 | 0000-00-00 | No | No | Current |
| 63629-8888-5 | 63629888805 | 90 TABLET in 1 BOTTLE (63629-8888-5) | 90 tablet | 2021-12-17 | 0000-00-00 | No | No | Current |
| 63629-8888-6 | 63629888806 | 120 TABLET in 1 BOTTLE (63629-8888-6) | 120 tablet | 2022-06-21 | 0000-00-00 | No | No | Current |