Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen, and Caffeine Tablets, USP50 mg/500 mg/40 mgRx OnlyRev. 11/03
Approved
Approval ID
6dd09be6-a345-4a42-9b64-51b7808ff45f
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, Acetaminophen and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-257
Application NumberANDA040336
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (10)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT