| NDC Code | 69101-600-08 |
|---|
| Package Description | 8 CUP, UNIT-DOSE in 1 TRAY (69101-600-08) > 15 mL in 1 CUP, UNIT-DOSE (69101-600-15) |
|---|
| Product NDC | 69101-600 |
|---|
| 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 | 20150318 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040834 |
|---|
| Manufacturer | Burke Therapeutics, LLC |
|---|
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
|---|
| Strength | 10; 325 |
|---|
| Strength Unit | mg/15mL; mg/15mL |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|