Butalbital, Aspirin, and Caffeine
Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIRevised: June 2009 1901100609
Approved
Approval ID
166e131d-9c1a-461f-bf33-e45d4ec36ff2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-922
Application NumberNDA017534
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateDecember 26, 2013
Generic Namebutalbital, aspirin, and caffeine
INGREDIENTS (10)
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
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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