Butalbital, Aspirin and Caffeine
Butalbital, Aspirin and Caffeine Tablets, USP
Approved
Approval ID
2ef4b16c-f553-4a79-b5ee-7893aeb0eae3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
Manufacturers
FDA
H.J. Harkins Company
DUNS: 147681894
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-370
Application NumberANDA086162
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (8)
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT