| NDC Code | 49999-608-01 |
|---|
| Package Description | 120 TABLET in 1 BOTTLE, PLASTIC (49999-608-01) |
|---|
| Product NDC | 49999-608 |
|---|
| 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 | 20100422 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040409 |
|---|
| Manufacturer | Lake Erie Medical DBA Quality Care Products LLC |
|---|
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
|---|
| Strength | 5; 325 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
|---|
| DEA Schedule | CIII |
|---|