Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/500 mg/40 mg
Approved
Approval ID
faf741c4-bfc5-4f52-8773-c50f7b15dd08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BUTALBITAL AND ACETAMINOPHEN AND CAFFEINE
PRODUCT DETAILS
NDC Product Code68387-520
Application NumberANDA040336
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 20, 2010
Generic NameBUTALBITAL AND ACETAMINOPHEN AND CAFFEINE
INGREDIENTS (11)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT