Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-1470
- 11-digit product format
- 713351470
- Labeler code
- 71335
- Product ID
- 71335-1470_07ec0b02-5410-4802-bd12-68e52f2426e5
- 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; 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1470-1 | 2024-05-20 | C162847 | 48780-1 | 1030e365-4010-111a-e063-dadaa90a10e2 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
| 71335-1470-2 | 2024-05-20 | C162847 | 48780-1 | 1030e365-4010-111a-e063-dadaa90a10e2 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
| 71335-1470-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4010-111a-e063-dadaa90a10e2 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
| 71335-1470-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4010-111a-e063-dadaa90a10e2 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1470-1 | Hydrocodone Bitartrate and Acetaminophen | 21 in 1 BOTTLE | TABLET | 21 | | 102 |
| 71335-1470-2 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 102 |
| 71335-1470-3 | Hydrocodone Bitartrate and Acetaminophen | 18 in 1 BOTTLE | TABLET | 18 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1470 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 3 package rows | 20240823_25d49886-9f9a-4015-bca2-9190b30d9120.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 |
|---|
| 71335-1470-1 | 71335147001 | 21 TABLET in 1 BOTTLE (71335-1470-1) | 21 tablet | 2020-01-14 | 0000-00-00 | No | No | Current |
| 71335-1470-2 | 71335147002 | 12 TABLET in 1 BOTTLE (71335-1470-2) | 12 tablet | 2020-08-19 | 0000-00-00 | No | No | Current |
| 71335-1470-3 | 71335147003 | 18 TABLET in 1 BOTTLE (71335-1470-3) | 18 tablet | 2024-08-12 | | No | No | Historical |