| NDC Code | 68682-306-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (68682-306-01) |
|---|
| Product NDC | 68682-306 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Butalbital And Acetaminophen |
|---|
| Non-Proprietary Name | Butalbital And Acetaminophen Tablets |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20170619 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA090956 |
|---|
| Manufacturer | Oceanside Pharmaceuticals |
|---|
| Substance Name | ACETAMINOPHEN; BUTALBITAL |
|---|
| Strength | 300; 50 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS] |
|---|
| DEA Schedule | CIII |
|---|