Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 76420-133
- 11-digit product format
- 764200133
- Labeler code
- 76420
- Product ID
- 76420-133_43413993-4070-bd37-e063-6294a90ac4a1
- 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; 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 |
|---|
| 76420-133-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 76420-133-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 76420-133-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 76420-133-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 76420-133-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-133 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 5 package rows | 20221013_d1de0f93-1439-4ee3-b692-56e1a1400682.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 |
|---|
| 76420-133-01 | 76420013301 | 100 TABLET in 1 BOTTLE (76420-133-01) | 100 tablet | 2025-11-10 | | No | No | Current |
| 76420-133-05 | 76420013305 | 500 TABLET in 1 BOTTLE (76420-133-05) | 500 tablet | 2025-11-10 | | No | No | Current |
| 76420-133-30 | 76420013330 | 30 TABLET in 1 BOTTLE (76420-133-30) | 30 tablet | 2020-12-16 | 0000-00-00 | No | No | Current |
| 76420-133-60 | 76420013360 | 60 TABLET in 1 BOTTLE (76420-133-60) | 60 tablet | 2025-11-10 | | No | No | Current |
| 76420-133-90 | 76420013390 | 90 TABLET in 1 BOTTLE (76420-133-90) | 90 tablet | 2025-11-10 | | No | No | Current |