Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 68071-4801
- 11-digit product format
- 680714801
- Labeler code
- 68071
- Product ID
- 68071-4801_1adc52ec-32da-70cf-e063-6294a90a0e66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2012-04-11
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- 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
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857002 |
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 |
|---|
| 68071-4801-2 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 5 |
| 68071-4801-6 | Hydrocodone Bitartrate and Acetaminophen | 6 in 1 BOTTLE | TABLET | 6 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4801 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240616_8592e901-9353-6fb6-e053-2a91aa0ad33b.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 |
|---|
| 68071-4801-2 | 68071480102 | 12 TABLET in 1 BOTTLE (68071-4801-2) | 12 tablet | 2019-04-02 | 0000-00-00 | No | No | Current |
| 68071-4801-6 | 68071480106 | 6 TABLET in 1 BOTTLE (68071-4801-6) | 6 tablet | 2019-04-02 | 0000-00-00 | No | No | Current |