hydrocodone bitartrate and acetaminophen
- Product NDC
- 64380-441
- 11-digit product format
- 643800441
- Labeler code
- 64380
- Product ID
- 64380-441_eb9cfb36-9266-4334-b613-38153715a9bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA202935
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- 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
- 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999, 857002, 857005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-441-01 | hydrocodone bitartrate and acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 64380-441-02 | hydrocodone bitartrate and acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 64380-441-03 | hydrocodone bitartrate and acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64380-441-01 | 64380044101 | 100 TABLET in 1 BOTTLE (64380-441-01) | 100 tablet | 2025-09-01 | No | No | Current |
| 64380-441-02 | 64380044102 | 500 in 1 BOTTLE | | | | | Historical |
| 64380-441-03 | 64380044103 | 1000 in 1 BOTTLE | | | | | Historical |