Butalbital, Aspirin and Caffeine
Butalbital, Aspirin, and Caffeine Tablets, USP CIIIRev. 04/03Rx Only
Approved
Approval ID
4e10129b-41a3-4572-9564-6f8366b627dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-354
Application NumberANDA086162
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB