| Product NDC: | 59630-170 |
| Proprietary Name: | Zebutal |
| Non Proprietary Name: | Butalbital, acetaminophen and caffeine |
| Active Ingredient(s): | 500; 50; 40 mg/1; mg/1; mg/1 & nbsp; Butalbital, acetaminophen and caffeine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59630-170 |
| Labeler Name: | Shionogi Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040261 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19981028 |
| Package NDC: | 59630-170-11 |
| Package Description: | 100 CAPSULE in 1 BOTTLE (59630-170-11) |
| NDC Code | 59630-170-11 |
| Proprietary Name | Zebutal |
| Package Description | 100 CAPSULE in 1 BOTTLE (59630-170-11) |
| Product NDC | 59630-170 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Butalbital, acetaminophen and caffeine |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 19981028 |
| Marketing Category Name | ANDA |
| Labeler Name | Shionogi Inc. |
| Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
| Strength Number | 500; 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] |