Tencon
Approved
Approval ID
4e4a9925-67aa-4be7-8bb7-c8b058ffe223
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
El Dorado Distributors LLC
DUNS: 118966668
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 Code11584-0030
Application NumberANDA089987
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
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