| NDC Code | 70518-2995-1 |
|---|
| Package Description | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2995-1) |
|---|
| Product NDC | 70518-2995 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Butalbital, Acetaminophen, Caffeine |
|---|
| Non-Proprietary Name | Butalbital, Acetaminophen, And Caffeine |
|---|
| Dosage Form | TABLET, COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20210119 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA209587 |
|---|
| Manufacturer | REMEDYREPACK INC. |
|---|
| Substance Name | ACETAMINOPHEN; BUTALBITAL; 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 |
|---|