Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-1444
- 11-digit product format
- 713351444
- Labeler code
- 71335
- Product ID
- 71335-1444_bac52248-7a3a-409d-9c6c-21852fb6a0a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-1444-1 | Hydrocodone Bitartrate and Acetaminophen | 21 in 1 BOTTLE | TABLET | 21 | | 103 |
| 71335-1444-2 | Hydrocodone Bitartrate and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 103 |
| 71335-1444-3 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1444 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 3 package rows | 20240725_418ea599-55e0-4d57-a4b1-16568e30f6f7.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 |
|---|
| 71335-1444-1 | 71335144401 | 21 TABLET in 1 BOTTLE (71335-1444-1) | 21 tablet | 2020-04-02 | 0000-00-00 | No | No | Current |
| 71335-1444-2 | 71335144402 | 15 TABLET in 1 BOTTLE (71335-1444-2) | 15 tablet | 2020-06-15 | 0000-00-00 | No | No | Current |
| 71335-1444-3 | 71335144403 | 10 TABLET in 1 BOTTLE (71335-1444-3) | 10 tablet | 2019-12-23 | 0000-00-00 | No | No | Current |