Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 70010-672
- 11-digit product format
- 700100672
- Labeler code
- 70010
- Product ID
- 70010-672_422263e3-1184-c7ea-e063-6294a90ae818
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA211729
- Marketing category
- ANDA
- Marketing start
- 2021-08-18
- 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 | NO70W886KK, 362O9ITL9D |
| Rxcui | 856999, 857002, 857005 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70010-672-01 | 2023-01-31 | C162847 | 48780-1 | f386c649-dbff-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg / 325 mg and 10 mg/325 mg CII Rx Only |
| 70010-672-01 | 2023-01-31 | C162847 | 48780-1 | f386c649-dbff-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg / 325 mg and 10 mg/325 mg CII Rx Only |
| 70010-672-05 | 2023-01-31 | C162847 | 48780-1 | f386c649-dbff-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg / 325 mg and 10 mg/325 mg CII Rx Only |
| 70010-672-05 | 2023-01-31 | C162847 | 48780-1 | f386c649-dbff-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg / 325 mg and 10 mg/325 mg CII Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-672-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 70010-672-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 17 |
| 70010-672-10 | Hydrocodone Bitartrate and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-672 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [GRANULES PHARMACEUTICALS INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20250227_136bbd47-7a54-493f-9158-a84d39221d6c.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 |
|---|
| 70010-672-01 | 70010067201 | 100 TABLET in 1 BOTTLE (70010-672-01) | 100 tablet | 2021-08-18 | 0000-00-00 | No | No | Current |
| 70010-672-05 | 70010067205 | 500 TABLET in 1 BOTTLE (70010-672-05) | 500 tablet | 2021-08-18 | 0000-00-00 | No | No | Current |
| 70010-672-10 | 70010067210 | 1000 TABLET in 1 BOTTLE (70010-672-10) | 1000 tablet | 2025-06-06 | | No | No | Historical |