| NDC Code | 85534-0046-2 |
|---|
| Package Description | 20 TABLET in 1 BOTTLE (85534-0046-2) |
|---|
| Product NDC | 85534-0046 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Butalbital, Acetaminophen, Caffeine |
|---|
| Non-Proprietary Name | Butalbital, Acetaminophen, And Caffeine |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190305 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA209587 |
|---|
| Manufacturer | HAWAII REPACK, INC. |
|---|
| Substance Name | BUTALBITAL; ACETAMINOPHEN; CAFFEINE |
|---|
| Strength | 325; 50; 40 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS] |
|---|
| DEA Schedule | CIII |
|---|