Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63187-658
- 11-digit product format
- 631870658
- Labeler code
- 63187
- Product ID
- 63187-658_53d10ccb-24f8-4d73-89ee-22bd08590f0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2012-04-12
- 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
- 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 | 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 |
|---|
| 63187-658-12 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 6 |
| 63187-658-15 | Hydrocodone Bitartrate and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 6 |
| 63187-658-20 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 6 |
| 63187-658-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 63187-658-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 63187-658-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-658 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 6 package rows | 20221020_e6711f26-a01d-43e8-882a-d58561e4b67f.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 |
|---|
| 63187-658-12 | 63187065812 | 12 TABLET in 1 BOTTLE (63187-658-12) | 12 tablet | 2021-03-03 | 0000-00-00 | No | No | Current |
| 63187-658-15 | 63187065815 | 15 TABLET in 1 BOTTLE (63187-658-15) | 15 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |
| 63187-658-20 | 63187065820 | 20 TABLET in 1 BOTTLE (63187-658-20) | 20 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |
| 63187-658-30 | 63187065830 | 30 TABLET in 1 BOTTLE (63187-658-30) | 30 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |
| 63187-658-60 | 63187065860 | 60 TABLET in 1 BOTTLE (63187-658-60) | 60 tablet | 2018-01-01 | 0000-00-00 | No | No | Current |
| 63187-658-90 | 63187065890 | 90 TABLET in 1 BOTTLE (63187-658-90) | 90 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |