Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 64950-343
- 11-digit product format
- 649500343
- Labeler code
- 64950
- Product ID
- 64950-343_9ec83613-4c13-4ab7-a71d-c100d30c1e30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- ANDA040894
- Marketing category
- ANDA
- Marketing start
- 2020-06-20
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 mg/15mL; mg/15mL
- 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/15mL |
| HYDROCODONE BITARTRATE | 7.5 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64950-343-11 | Hydrocodone Bitartrate and Acetaminophen | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 5 |
| 64950-343-16 | Hydrocodone Bitartrate and Acetaminophen | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-343 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [GENUS LIFESCIENCES INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240823_26242cd7-1dbe-4ca4-88ca-5b98a6566ff9.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 |
|---|
| 64950-343-11 | 64950034311 | 118 mL in 1 BOTTLE (64950-343-11) | 118 ml | 2020-06-20 | | No | No | Historical |
| 64950-343-16 | 64950034316 | 473 mL in 1 BOTTLE (64950-343-16) | 473 ml | 2020-06-20 | 0000-00-00 | No | No | Current |