FDA.reportPublic FDA data

Alosetron

Product NDC
63629-2517
11-digit product format
636292517
Labeler code
63629
Product ID
63629-2517_6be48a5b-38ea-45da-b4ad-03ad595e4744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alosetron
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213614
Marketing category
ANDA
Marketing start
2020-09-14
Substance
ALOSETRON HYDROCHLORIDE
Active strength
.5 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
Alosetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOSETRON HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2F5R1A46YW
Rxcui403975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a726e57-9bfe-419e-b2fb-835ed905be3dProduct name620210511

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-2517-12024-01-30C16284748780-11030e364-f919-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALOSETRON TABLETS safely and effectively. See full prescribing information for ALOSETRON TABLETS. ALOSETRON tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2517-1Alosetron30 in 1 BOTTLETABLET30102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2517ALOSETRON TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20220504_da94d161-0bf0-48fe-90f4-8e38ae18e1ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403975alosetron HCl 0.5 MG Oral TabletPSNda94d161-0bf0-48fe-90f4-8e38ae18e1ca102
403975alosetron 0.5 MG Oral TabletSCDda94d161-0bf0-48fe-90f4-8e38ae18e1ca102
403975alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral TabletSYda94d161-0bf0-48fe-90f4-8e38ae18e1ca102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2517-16362925170130 TABLET in 1 BOTTLE (63629-2517-1) 30 tablet2022-04-290000-00-00NoNoCurrent