Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-2105
- 11-digit product format
- 713352105
- Labeler code
- 71335
- Product ID
- 71335-2105_cb5ff3f5-c6c8-461f-b768-cd916d066e7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2018-11-08
- 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 |
|---|
| 71335-2105-1 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 102 |
| 71335-2105-2 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 102 |
| 71335-2105-3 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 102 |
| 71335-2105-4 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 102 |
| 71335-2105-5 | Hydrocodone Bitartrate and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2105 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 5 package rows | 20231027_5d5fa7bb-6416-48dc-95a0-43ffd84cb595.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 |
|---|
| 71335-2105-1 | 71335210501 | 30 TABLET in 1 BOTTLE (71335-2105-1) | 30 tablet | 2022-06-06 | 0000-00-00 | No | No | Current |
| 71335-2105-2 | 71335210502 | 20 TABLET in 1 BOTTLE (71335-2105-2) | 20 tablet | 2022-06-06 | 0000-00-00 | No | No | Current |
| 71335-2105-3 | 71335210503 | 60 TABLET in 1 BOTTLE (71335-2105-3) | 60 tablet | 2022-06-06 | 0000-00-00 | No | No | Current |
| 71335-2105-4 | 71335210504 | 90 TABLET in 1 BOTTLE (71335-2105-4) | 90 tablet | 2022-06-06 | 0000-00-00 | No | No | Current |
| 71335-2105-5 | 71335210505 | 120 TABLET in 1 BOTTLE (71335-2105-5) | 120 tablet | 2022-06-06 | 0000-00-00 | No | No | Current |