Alosetron Hydrochloride
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
2927e7d0-b1b8-4944-a7e8-97b60eb9bb71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alosetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53746-249
Application NumberANDA206647
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alosetron Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALOSETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Alosetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53746-248
Application NumberANDA206647
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alosetron Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (9)
ALOSETRON HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT