| Product NDC: | 0095-7029 |
| Proprietary Name: | Orbivan |
| Non Proprietary Name: | Acetaminophen, butalbital and caffeine |
| Active Ingredient(s): | 300; 50; 40 mg/1; mg/1; mg/1 & nbsp; Acetaminophen, butalbital and caffeine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0095-7029 |
| Labeler Name: | ECR Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040885 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120821 |
| Package NDC: | 0095-7029-01 |
| Package Description: | 100 CAPSULE in 1 BOTTLE (0095-7029-01) |
| NDC Code | 0095-7029-01 |
| Proprietary Name | Orbivan |
| Package Description | 100 CAPSULE in 1 BOTTLE (0095-7029-01) |
| Product NDC | 0095-7029 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Acetaminophen, butalbital and caffeine |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120821 |
| Marketing Category Name | ANDA |
| Labeler Name | ECR Pharmaceuticals |
| Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
| Strength Number | 300; 50; 40 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmaceutical Classes | Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] |