Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63629-8886
- 11-digit product format
- 636298886
- Labeler code
- 63629
- Product ID
- 63629-8886_be9a4264-2327-4dcb-b370-3f9ae9ede6ae
- 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; 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 |
|---|
| 63629-8886-1 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 103 |
| 63629-8886-2 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 103 |
| 63629-8886-3 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 103 |
| 63629-8886-4 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 103 |
| 63629-8886-5 | Hydrocodone Bitartrate and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8886 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 5 package rows | 20240913_42a74abc-bdc7-4ea3-a185-029340111730.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 |
|---|
| 63629-8886-1 | 63629888601 | 30 TABLET in 1 BOTTLE (63629-8886-1) | 30 tablet | 2021-10-06 | 0000-00-00 | No | No | Current |
| 63629-8886-2 | 63629888602 | 20 TABLET in 1 BOTTLE (63629-8886-2) | 20 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 63629-8886-3 | 63629888603 | 60 TABLET in 1 BOTTLE (63629-8886-3) | 60 tablet | 2021-10-06 | 0000-00-00 | No | No | Current |
| 63629-8886-4 | 63629888604 | 90 TABLET in 1 BOTTLE (63629-8886-4) | 90 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 63629-8886-5 | 63629888605 | 120 TABLET in 1 BOTTLE (63629-8886-5) | 120 tablet | 2021-10-13 | 0000-00-00 | No | No | Current |