| NDC Code | 66689-005-50 |
|---|
| Package Description | 50 CUP, UNIT-DOSE in 1 CASE (66689-005-50) / 10 mL in 1 CUP, UNIT-DOSE (66689-005-01) |
|---|
| Product NDC | 66689-005 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190624 |
|---|
| End Marketing Date | 20241130 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA200343 |
|---|
| Manufacturer | VistaPharm, LLC |
|---|
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
|---|
| Strength | 217; 5 |
|---|
| Strength Unit | mg/10mL; mg/10mL |
|---|
| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|