BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine Tablets, USP 8239601/0817 Rx only
Approved
Approval ID
92a81a1f-698b-4db0-b5a6-f7562abd9a32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2022
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
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 Code55154-7147
Application NumberANDA040511
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2021
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT