Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 64950-373
- 11-digit product format
- 649500373
- Labeler code
- 64950
- Product ID
- 64950-373_fa4d198c-5525-42d1-adea-04dcc863788d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- ANDA040838
- Marketing category
- ANDA
- Marketing start
- 2023-10-15
- 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
- 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/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 |
|---|
| 64950-373-04 | Hydrocodone Bitartrate and Acetaminophen | 4 mL in 1 BOTTLE | SOLUTION | 4 | | 4 |
| 64950-373-16 | Hydrocodone Bitartrate and Acetaminophen | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-373 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [GENUS LIFESCIENCES INC.] | 3 | Current NDC, 2 package rows | 20241116_a9fb9779-76a5-407a-a155-84f198004ae2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64950-373-04 | 64950037304 | 4 mL in 1 BOTTLE (64950-373-04) | 4 ml | 2023-10-15 | No | No | Current |
| 64950-373-16 | 64950037316 | 473 mL in 1 BOTTLE (64950-373-16) | 473 ml | 2023-10-15 | No | No | Current |