Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 68071-3685
- 11-digit product format
- 680713685
- Labeler code
- 68071
- Product ID
- 68071-3685_226765d3-3226-2302-e063-6394a90a27a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA202214
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3685-6 | Hydrocodone Bitartrate and Acetaminophen | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3685 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240920_226765e9-a6b1-22b6-e063-6394a90a364e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3685-6 | 68071368506 | 6 TABLET in 1 BOTTLE, PLASTIC (68071-3685-6) | 6 tablet | 2024-09-18 | No | No | Current |