Butalbital and Acetaminophen
Butalbital and Acetaminophen Tablets 50 mg/300 mg
Approved
Approval ID
a24ccca7-e347-44e4-b700-1cc54c525bd3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 13, 2020
Manufacturers
FDA
LGM Pharma Solutions, LLC
DUNS: 117549198
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 Code79739-7075
Application NumberANDA090956
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2020
FDA Product Classification
INGREDIENTS (2)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB