Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-1970
- 11-digit product format
- 713351970
- Labeler code
- 71335
- Product ID
- 71335-1970_fbff8b13-b5c4-4bfa-bd49-568fe4150ca3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210211
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1970-1 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 104 |
| 71335-1970-2 | Hydrocodone Bitartrate and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 104 |
| 71335-1970-3 | Hydrocodone Bitartrate and Acetaminophen | 28 in 1 BOTTLE | TABLET | 28 | | 104 |
| 71335-1970-4 | Hydrocodone Bitartrate and Acetaminophen | 56 in 1 BOTTLE | TABLET | 56 | | 104 |
| 71335-1970-5 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 104 |
| 71335-1970-6 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 104 |
| 71335-1970-7 | Hydrocodone Bitartrate and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1970 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 7 package rows | 20240915_080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7.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 |
|---|
| 71335-1970-1 | 71335197001 | 30 TABLET in 1 BOTTLE (71335-1970-1) | 30 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 71335-1970-2 | 71335197002 | 15 TABLET in 1 BOTTLE (71335-1970-2) | 15 tablet | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-1970-3 | 71335197003 | 28 TABLET in 1 BOTTLE (71335-1970-3) | 28 tablet | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-1970-4 | 71335197004 | 56 TABLET in 1 BOTTLE (71335-1970-4) | 56 tablet | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-1970-5 | 71335197005 | 60 TABLET in 1 BOTTLE (71335-1970-5) | 60 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 71335-1970-6 | 71335197006 | 90 TABLET in 1 BOTTLE (71335-1970-6) | 90 tablet | 2021-10-26 | 0000-00-00 | No | No | Current |
| 71335-1970-7 | 71335197007 | 120 TABLET in 1 BOTTLE (71335-1970-7) | 120 tablet | 2021-10-26 | 0000-00-00 | No | No | Current |