Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 68071-2494
- 11-digit product format
- 680712494
- Labeler code
- 68071
- Product ID
- 68071-2494_14a72a34-8d02-37f6-e063-6394a90aed3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA210211
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857005 |
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 |
|---|
| 68071-2494-2 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 2 |
| 68071-2494-6 | Hydrocodone Bitartrate and Acetaminophen | 6 in 1 BOTTLE | TABLET | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2494 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240328_c8d65aab-d6ae-bc69-e053-2a95a90a7b5e.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 |
|---|
| 68071-2494-2 | 68071249402 | 12 TABLET in 1 BOTTLE (68071-2494-2) | 12 tablet | 2021-08-05 | | No | No | Current |
| 68071-2494-6 | 68071249406 | 6 TABLET in 1 BOTTLE (68071-2494-6) | 6 tablet | 2021-08-05 | 0000-00-00 | No | No | Current |