Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63629-8499
- 11-digit product format
- 636298499
- Labeler code
- 63629
- Product ID
- 63629-8499_8aa0ab43-7cd6-4210-8cdb-fdc03a774705
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202991
- Marketing category
- ANDA
- Marketing start
- 2016-04-12
- 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
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8499-1 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8499 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20240820_380ff458-d5d7-422e-ac96-e9a56ade16b6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8499-1 | 63629849901 | 100 TABLET in 1 BOTTLE (63629-8499-1) | 100 tablet | 2016-04-12 | 0000-00-00 | No | No | Current |