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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-922
Application NumberNDA017534
Product Classification
M
Marketing Category
C73605
G
Generic Name
butalbital, aspirin, and caffeine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2013
FDA Product Classification
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