FDA.reportPublic FDA data

Alosetron Hydrochloride

Product NDC
0054-0295
Requested package NDC
0054-0295-13
11-digit product format
000540295
Labeler code
0054
Product ID
0054-0295_ca09da58-08c8-4520-b2a7-f33d3feaa15f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alosetron hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA200652
Marketing category
ANDA
Marketing start
2013-07-15
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
2022-12-31
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 packagepackage0054-02950054-0295-13DDiscontinued 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
A200652-001ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2015-05-04
A200652-002ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2015-05-04

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 22:54:322026-06A200652-001ALOSETRON HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2015-05-04a50c72e98297…
2026-08-01 22:54:322026-06A200652-002ALOSETRON HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2015-05-04a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0295-13EA - Each0054-029519da37ec-eb80-407f-9963-b044a027a6ef12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALOSETRON HYDROCHLORIDEACTIVE INGREDIENT2F5R1A46YWALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.]1
ALOSETRONACTIVE MOIETY13Z9HTH115ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0295-130005402951330 TABLET in 1 BOTTLE (0054-0295-13) 30 tablet2015-05-040000-00-00NoNoCurrent