Alosetron
These highlights do not include all the information needed to use ALOSETRON TABLETS safely and effectively. See full prescribing information for ALOSETRON TABLETS. ALOSETRON tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
da94d161-0bf0-48fe-90f4-8e38ae18e1ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2022
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2517
Application NumberANDA213614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alosetron
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2022
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
ALOSETRON HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT