Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 43386-352
- 11-digit product format
- 433860352
- Labeler code
- 43386
- Product ID
- 43386-352_cc982f78-de8c-4384-9f43-ffad4169abdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA206142
- Marketing category
- ANDA
- Marketing start
- 2016-11-14
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 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 | 300 mg/1 |
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856980, 856987, 856992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-352-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 43386-352-03 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 43386-352-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-352 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LUPIN PHARMACEUTICALS,INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241204_48cc1378-ffab-4645-95bb-a05d78066575.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 |
|---|
| 43386-352-01 | 43386035201 | 100 TABLET in 1 BOTTLE (43386-352-01) | 100 tablet | 2016-11-14 | 0000-00-00 | No | No | Current |
| 43386-352-03 | 43386035203 | 30 TABLET in 1 BOTTLE (43386-352-03) | 30 tablet | 2016-11-14 | 0000-00-00 | No | No | Current |
| 43386-352-05 | 43386035205 | 500 TABLET in 1 BOTTLE (43386-352-05) | 500 tablet | 2016-11-14 | 0000-00-00 | No | No | Current |