| NDC Code | 64380-440-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (64380-440-01) |
|---|
| Product NDC | 64380-440 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20250701 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA202935 |
|---|
| Manufacturer | Strides Pharma Science Limited |
|---|
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
|---|
| Strength | 325; 5 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|