Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 43386-357
- 11-digit product format
- 433860357
- Labeler code
- 43386
- Product ID
- 43386-357_2cb73d19-0ef9-4d59-a2de-b7b2b3a369a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA206245
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- 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 | NO70W886KK, 362O9ITL9D |
| Rxcui | 856999, 857002, 857005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-357-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 43386-357-03 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 43386-357-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 43386-357-10 | Hydrocodone Bitartrate and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-357 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LUPIN PHARMACEUTICALS,INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241204_26a2178e-e0e5-4d61-81fd-e30a3142f1f2.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 |
|---|
| 43386-357-01 | 43386035701 | 100 TABLET in 1 BOTTLE (43386-357-01) | 100 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 43386-357-03 | 43386035703 | 30 TABLET in 1 BOTTLE (43386-357-03) | 30 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 43386-357-05 | 43386035705 | 500 TABLET in 1 BOTTLE (43386-357-05) | 500 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 43386-357-10 | 43386035710 | 1000 TABLET in 1 BOTTLE (43386-357-10) | 1000 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |