FDA.reportPublic FDA data

LOTRONEX

Product NDC
65483-895
11-digit product format
654830895
Labeler code
65483
Product ID
65483-895_800b0802-c4e6-409f-adbc-a985d1fca2a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alosetron hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Prometheus Laboratories Inc.
Application
NDA021107
Marketing category
NDA
Marketing start
2009-02-09
Marketing end
0000-00-00
Substance
ALOSETRON HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65483-895IInactivated by FDA2026-07-31
excluded packagepackage65483-89565483-895-03IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021107-001LOTRONEXALOSETRON HYDROCHLORIDEEQ 1MG BASETABLET / ORALABRLD, RS2000-02-09
N021107-002LOTRONEXALOSETRON HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALABRLD2003-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021107-001AB
N021107-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021107-001LOTRONEXEQ 1MG BASETABLET / ORALABRLD, RS2000-02-09a50c72e98297…
2026-08-01 22:54:322026-06N021107-002LOTRONEXEQ 0.5MG BASETABLET / ORALABRLD2003-12-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021107-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021107-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOTRONEXALOSETRON HYDROCHLORIDESebela Pharmaceuticals Inc.35cbb9d5-639b-207a-e054-00144ff88e882026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021107
application number: NDA021107
LOTRONEXALOSETRON HYDROCHLORIDELegacy Pharma USA Inc.c216e967-436f-475a-8e6a-2ad11adc63af2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021107
application number: NDA021107

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65483-895-032020-01-31C16284748780-19d75b9d0-8095-f424-e053-dadaa90a57ceThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65483-895-03LOTRONEX30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65483-895-03EA - Each65483-89553579187-d54c-463f-80f3-08e826495f1912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alosetron hydrochlorideACTIVE INGREDIENT2F5R1A46YWLOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
alosetronACTIVE MOIETY13Z9HTH115LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
indigotindisulfonate sodiumINACTIVE INGREDIENTD3741U8K7LLOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
lactoseINACTIVE INGREDIENTJ2B2A4N98GLOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
magnesium stearateINACTIVE INGREDIENT70097M6I30LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
starch, cornINACTIVE INGREDIENTO8232NY3SJLOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9
triacetinINACTIVE INGREDIENTXHX3C3X673LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65483-895LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]10Legacy NDC, 1 package rows20160121_526ba44c-a476-4675-a63c-4d0a72b723f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403975alosetron HCl 0.5 MG Oral TabletPSN526ba44c-a476-4675-a63c-4d0a72b723f510
259306alosetron HCl 1 MG Oral TabletPSN526ba44c-a476-4675-a63c-4d0a72b723f510
540181Lotronex 0.5 MG Oral TabletPSN526ba44c-a476-4675-a63c-4d0a72b723f510
261362Lotronex 1 MG Oral TabletPSN526ba44c-a476-4675-a63c-4d0a72b723f510
540181alosetron 0.5 MG Oral Tablet [Lotronex]SBD526ba44c-a476-4675-a63c-4d0a72b723f510
261362alosetron 1 MG Oral Tablet [Lotronex]SBD526ba44c-a476-4675-a63c-4d0a72b723f510
403975alosetron 0.5 MG Oral TabletSCD526ba44c-a476-4675-a63c-4d0a72b723f510
259306alosetron 1 MG Oral TabletSCD526ba44c-a476-4675-a63c-4d0a72b723f510
403975alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral TabletSY526ba44c-a476-4675-a63c-4d0a72b723f510
259306alosetron 1 MG (as alosetron HCl 1.124 MG) Oral TabletSY526ba44c-a476-4675-a63c-4d0a72b723f510
540181Lotronex 0.5 MG (alosetron hydrochloride 0.562 MG) Oral TabletSY526ba44c-a476-4675-a63c-4d0a72b723f510
540181Lotronex 0.5 MG Oral TabletSY526ba44c-a476-4675-a63c-4d0a72b723f510
261362Lotronex 1 MG (alosetron hydrochloride 1.124 MG) Oral TabletSY526ba44c-a476-4675-a63c-4d0a72b723f510
261362Lotronex 1 MG Oral TabletSY526ba44c-a476-4675-a63c-4d0a72b723f510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65483-895-036548308950330 in 1 BOTTLEHistorical