FDA.reportPublic FDA data

LOTRONEX

Product NDC
83107-012
11-digit product format
831070012
Labeler code
83107
Product ID
83107-012_4db1d464-27cc-80a9-e063-6394a90ade00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alosetron hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharma USA Inc.
Application
NDA021107
Marketing category
NDA
Marketing start
2026-01-01
Substance
ALOSETRON HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOTRONEX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOSETRON HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2F5R1A46YW
Rxcui259306, 261362, 403975, 540181

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
9a726e57-9bfe-419e-b2fb-835ed905be3dProduct name620210511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83107-012-30LOTRONEX30 in 1 BOTTLETABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403975alosetron HCl 0.5 MG Oral TabletPSNc216e967-436f-475a-8e6a-2ad11adc63af2
259306alosetron HCl 1 MG Oral TabletPSNc216e967-436f-475a-8e6a-2ad11adc63af2
540181Lotronex 0.5 MG Oral TabletPSNc216e967-436f-475a-8e6a-2ad11adc63af2
261362Lotronex 1 MG Oral TabletPSNc216e967-436f-475a-8e6a-2ad11adc63af2
540181alosetron 0.5 MG Oral Tablet [Lotronex]SBDc216e967-436f-475a-8e6a-2ad11adc63af2
261362alosetron 1 MG Oral Tablet [Lotronex]SBDc216e967-436f-475a-8e6a-2ad11adc63af2
403975alosetron 0.5 MG Oral TabletSCDc216e967-436f-475a-8e6a-2ad11adc63af2
259306alosetron 1 MG Oral TabletSCDc216e967-436f-475a-8e6a-2ad11adc63af2
403975alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral TabletSYc216e967-436f-475a-8e6a-2ad11adc63af2
259306alosetron 1 MG (as alosetron HCl 1.124 MG) Oral TabletSYc216e967-436f-475a-8e6a-2ad11adc63af2
540181Lotronex 0.5 MG (alosetron hydrochloride 0.562 MG) Oral TabletSYc216e967-436f-475a-8e6a-2ad11adc63af2
540181Lotronex 0.5 MG Oral TabletSYc216e967-436f-475a-8e6a-2ad11adc63af2
261362Lotronex 1 MG (alosetron hydrochloride 1.124 MG) Oral TabletSYc216e967-436f-475a-8e6a-2ad11adc63af2
261362Lotronex 1 MG Oral TabletSYc216e967-436f-475a-8e6a-2ad11adc63af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83107-012-308310700123030 TABLET in 1 BOTTLE (83107-012-30) 30 tablet2026-01-01NoNoHistorical