Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 68071-2664
- 11-digit product format
- 680712664
- Labeler code
- 68071
- Product ID
- 68071-2664_e00260a7-54a8-c99c-e053-2995a90a2a74
- 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
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 68071-2664-2 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 2 |
| 68071-2664-6 | 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 |
|---|
| 68071-2664 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC, 2 package rows | 20220528_db49f453-2211-4969-e053-2995a90abb0f.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 |
|---|
| 68071-2664-2 | 68071266402 | 12 TABLET in 1 BOTTLE (68071-2664-2) | 12 tablet | 2022-03-28 | 0000-00-00 | No | No | Current |
| 68071-2664-6 | 68071266406 | 6 TABLET in 1 BOTTLE (68071-2664-6) | 6 tablet | 2022-03-28 | 0000-00-00 | No | No | Current |