Butalbital, Acetaminophen and Caffeine
Approved
Approval ID
8c330933-ee51-4261-917e-155fddf1b711
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-1036
Application NumberANDA089718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2011
FDA Product Classification
INGREDIENTS (8)
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIM
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 6/29/2010
Revised 04/03
Rx Only