Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-2585
- 11-digit product format
- 713352585
- Labeler code
- 71335
- Product ID
- 71335-2585_d38676e7-b7fe-4ff4-a60c-90f3f981064f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202214
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2027-12-31
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 |
|---|
| 71335-2585-1 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71335-2585-2 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 71335-2585-3 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 71335-2585-4 | Hydrocodone Bitartrate and Acetaminophen | 8 in 1 BOTTLE | TABLET | 8 | | 2 |
| 71335-2585-5 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 2 |
| 71335-2585-6 | Hydrocodone Bitartrate and Acetaminophen | 28 in 1 BOTTLE | TABLET | 28 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2585 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 1 | Current NDC, 6 package rows | 20250410_806a981f-85ff-4e58-8ff0-7ab02ed2e5c1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2585-1 | 71335258501 | 30 TABLET in 1 BOTTLE (71335-2585-1) | 30 tablet | 2025-04-03 | No | No | Historical |
| 71335-2585-2 | 71335258502 | 60 TABLET in 1 BOTTLE (71335-2585-2) | 60 tablet | 2025-04-03 | No | No | Historical |
| 71335-2585-3 | 71335258503 | 90 TABLET in 1 BOTTLE (71335-2585-3) | 90 tablet | 2025-04-03 | No | No | Historical |
| 71335-2585-4 | 71335258504 | 8 TABLET in 1 BOTTLE (71335-2585-4) | 8 tablet | 2025-04-03 | No | No | Historical |
| 71335-2585-5 | 71335258505 | 20 TABLET in 1 BOTTLE (71335-2585-5) | 20 tablet | 2025-04-03 | No | No | Historical |
| 71335-2585-6 | 71335258506 | 28 TABLET in 1 BOTTLE (71335-2585-6) | 28 tablet | 2025-04-03 | No | No | Historical |