Butalbital and Acetaminophen
Butalbital and Acetaminophen Tablets 50 mg/300 mg
Approved
Approval ID
669e3bd0-fbd9-423c-8654-a78fe650e3e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 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 and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0722-7075
Application NumberANDA090956
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (2)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB