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) TabletsInitial U.S. Approval: 2000
Approved
Approval ID
526ba44c-a476-4675-a63c-4d0a72b723f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2016
Manufacturers
FDA
Prometheus Laboratories Inc.
DUNS: 967000860
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 Code65483-895
Application NumberNDA021107
Product Classification
M
Marketing Category
C73594
G
Generic Name
alosetron hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2016
FDA Product Classification
INGREDIENTS (9)
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
alosetron hydrochlorideActive
Quantity: 1.0 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
indigotindisulfonate sodiumInactive
Code: D3741U8K7L
Classification: IACT
alosetron hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65483-894
Application NumberNDA021107
Product Classification
M
Marketing Category
C73594
G
Generic Name
alosetron hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2016
FDA Product Classification
INGREDIENTS (8)
alosetron hydrochlorideActive
Quantity: 0.5 mg in 1 1
Code: 2F5R1A46YW
Classification: ACTIM
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT