Butalbital, Aspirin and Caffeine
Butalbital, Aspirin and Caffeine Tablets, USP
Approved
Approval ID
657e4c4a-e50c-49f7-99b4-32395ec19bd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2011
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Butalbital, Aspirin and Caffeine
PRODUCT DETAILS
NDC Product Code66336-619
Application NumberANDA086162
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 1, 2011
Generic NameButalbital, Aspirin and Caffeine
INGREDIENTS (8)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT