Oxycodone and Acetaminophen
- Product NDC
- 68071-5054
- 11-digit product format
- 680715054
- Labeler code
- 68071
- Product ID
- 68071-5054_1b430bed-5a73-54e5-e063-6394a90a946e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-5054-2 | Oxycodone and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 6 |
| 68071-5054-4 | Oxycodone and Acetaminophen | 4 in 1 BOTTLE | TABLET | 4 | | 6 |
| 68071-5054-6 | Oxycodone and Acetaminophen | 6 in 1 BOTTLE | TABLET | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5054 | OXYCODONE AND ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240620_925f9787-3d1c-0189-e053-2a95a90a2972.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 |
|---|
| 68071-5054-2 | 68071505402 | 12 TABLET in 1 BOTTLE (68071-5054-2) | 12 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |
| 68071-5054-4 | 68071505404 | 4 TABLET in 1 BOTTLE (68071-5054-4) | 4 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |
| 68071-5054-6 | 68071505406 | 6 TABLET in 1 BOTTLE (68071-5054-6) | 6 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |