LOTRONEX
These highlights do not include all the information needed to use LOTRONEX safely and effectively. See full prescribing information for LOTRONEX. LOTRONEX (alosetron hydrochloride) Tablets Initial U.S. Approval: 2000
Approved
Approval ID
35cbb9d5-639b-207a-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2019
Manufacturers
FDA
Sebela Pharmaceuticals Inc.
DUNS: 079104574
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 Code54766-894
Application NumberNDA021107
Product Classification
M
Marketing Category
C73594
G
Generic Name
alosetron hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2019
FDA Product Classification
INGREDIENTS (8)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALOSETRON HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
alosetron hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54766-895
Application NumberNDA021107
Product Classification
M
Marketing Category
C73594
G
Generic Name
alosetron hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2019
FDA Product Classification
INGREDIENTS (9)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALOSETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT