Alosetron Hydrochloride

Product NDC
73190-035
11-digit product format
731900035
Labeler code
73190
Product ID
73190-035_3e64c1e9-713c-8f82-e063-6394a90a7bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alosetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA206647
Marketing category
ANDA
Marketing start
2025-07-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alosetron Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2F5R1A46YW
Rxcui259306, 403975

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73190-035-30Alosetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-035-30EA - Each73190-0352cb813f3-56d7-4a1c-96fb-80a132ed2b0212025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403975alosetron HCl 0.5 MG Oral TabletPSN3ac203a2-4c55-deac-e063-6394a90aa1653
259306alosetron HCl 1 MG Oral TabletPSN3ac203a2-4c55-deac-e063-6394a90aa1653
403975alosetron 0.5 MG Oral TabletSCD3ac203a2-4c55-deac-e063-6394a90aa1653
259306alosetron 1 MG Oral TabletSCD3ac203a2-4c55-deac-e063-6394a90aa1653
403975alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral TabletSY3ac203a2-4c55-deac-e063-6394a90aa1653
259306alosetron 1 MG (as alosetron HCl 1.124 MG) Oral TabletSY3ac203a2-4c55-deac-e063-6394a90aa1653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-035-307319000353030 TABLET, FILM COATED in 1 BOTTLE (73190-035-30) 2025-07-25NoNoCurrent