| Product NDC: | 49999-115 | 
| Proprietary Name: | Butalbital, Aspirin and Caffeine | 
| Non Proprietary Name: | Butalbital, Aspirin and Caffeine | 
| Active Ingredient(s): | 325; 50; 40 mg/1; mg/1; mg/1 & nbsp; Butalbital, Aspirin and Caffeine | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 49999-115 | 
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA086162 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20120223 | 
| Package NDC: | 49999-115-60 | 
| Package Description: | 60 TABLET in 1 BOTTLE (49999-115-60) | 
| NDC Code | 49999-115-60 | 
| Proprietary Name | Butalbital, Aspirin and Caffeine | 
| Package Description | 60 TABLET in 1 BOTTLE (49999-115-60) | 
| Product NDC | 49999-115 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Butalbital, Aspirin and Caffeine | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20120223 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Substance Name | ASPIRIN; BUTALBITAL; CAFFEINE | 
| Strength Number | 325; 50; 40 | 
| Strength Unit | mg/1; mg/1; mg/1 | 
| Pharmaceutical Classes | Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] |