Butalbital, Acetaminophen, and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
Approved
Approval ID
da9e77e3-9f64-402a-83ac-eb0dc3cd1abe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 3, 2019
Manufacturers
FDA
Nexgen Pharma, Inc.
DUNS: 048488621
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 Code0722-7320
Application NumberANDA209587
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen, and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2019
FDA Product Classification
INGREDIENTS (7)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (19 MPA.S AT 5%)Inactive
Code: 6B46OH7T95
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT