Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 76420-215
- 11-digit product format
- 764200215
- Labeler code
- 76420
- Product ID
- 76420-215_dea38bcd-012c-0949-e053-2a95a90a8f7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA202991
- Marketing category
- ANDA
- Marketing start
- 2016-04-12
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-215-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 76420-215-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 76420-215-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 76420-215-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-215 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20220511_5c00f98f-dcab-4bdb-901e-02eb873dea31.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 |
|---|
| 76420-215-01 | 76420021501 | 100 TABLET in 1 BOTTLE (76420-215-01) | 100 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |
| 76420-215-30 | 76420021530 | 30 TABLET in 1 BOTTLE (76420-215-30) | 30 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |
| 76420-215-60 | 76420021560 | 60 TABLET in 1 BOTTLE (76420-215-60) | 60 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |
| 76420-215-90 | 76420021590 | 90 TABLET in 1 BOTTLE (76420-215-90) | 90 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |