FDA.reportPublic FDA data

Alosetron Hydrochloride

Product NDC
45963-479
Requested package NDC
45963-479-03
11-digit product format
459630479
Labeler code
45963
Product ID
45963-479_963590cd-862a-cf1d-e053-2a95a90af4c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alosetron hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA021107
Marketing category
NDA
Marketing start
2015-05-26
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
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45963-47945963-479-03DDiscontinued by firm2026-07-31

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-479-03EA - Each45963-4799a39d7f1-9901-4227-9ba0-b976b5023b0812015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alosetron hydrochlorideACTIVE INGREDIENT2F5R1A46YWALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
alosetronACTIVE MOIETY13Z9HTH115ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
indigotindisulfonate sodiumINACTIVE INGREDIENTD3741U8K7LALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
lactoseINACTIVE INGREDIENTJ2B2A4N98GALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4
triacetinINACTIVE INGREDIENTXHX3C3X673ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-479ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]11Legacy NDC20241215_969429cb-60b9-4a9c-be60-dd01994431b2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45963-479-03459630479031 BOTTLE in 1 CARTON (45963-479-03) > 30 TABLET in 1 BOTTLE1 bottle2015-05-260000-00-00NoNoCurrent