Butalbital, Aspirin, and Caffeine
Butalbital, Aspirin, and Caffeine Capsules
Approved
Approval ID
aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 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 Code21695-139
Application NumberANDA086231
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital, aspirin, and caffeine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2008
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
butalbitalActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
aspirinActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
caffeineActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT