ZELNORM
These highlights do not include all the information needed to use ZELNORM safely and effectively. See full prescribing information for ZELNORM . ZELNORM (tegaserod) tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
6a44eefe-fbe8-431c-a418-2571b26aa42e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2020
Manufacturers
FDA
Alfasigma USA, Inc.
DUNS: 079115380
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tegaserod
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0525-0971
Application NumberNDA021200
Product Classification
M
Marketing Category
C73594
G
Generic Name
tegaserod
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2020
FDA Product Classification
INGREDIENTS (6)
TEGASERODActive
Quantity: 6 mg in 1 1
Code: 458VC51857
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT