Butalbital, Acetaminophen, and Caffeine
Butalbital,Acetaminophen, andCaffeine Tablets, USP
Approved
Approval ID
a04406b8-08fc-4d44-8b3c-63da3d7fb55b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-553
Application NumberANDA089718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen, and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2012
FDA Product Classification
INGREDIENTS (8)
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT