Butalbital, Acetaminophen, and Caffeine
Butalbital, Acetaminophen, and Caffeine Capsules Rx only
Approved
Approval ID
611356c6-9cf6-4316-a9cb-e7756955755b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 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 Capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0722-7029
Application NumberANDA040885
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen, and Caffeine Capsules
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2019
FDA Product Classification
INGREDIENTS (3)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB