Alosetron Hydrochloride

Product NDC
71930-011
11-digit product format
719300011
Labeler code
71930
Product ID
71930-011_c304be8d-9fa3-4d89-885e-5a6bf1e80a2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alosetron Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA211621
Marketing category
ANDA
Marketing start
2019-02-01
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
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 HYDROCHLORIDE1 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
71930-011-30Alosetron Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-011-30EA - Each71930-011ed161506-ef84-4609-a272-af9f757bac8812025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403975alosetron HCl 0.5 MG Oral TabletPSNd62b2c5a-1693-4e67-96d5-197e1fdc86943
259306alosetron HCl 1 MG Oral TabletPSNd62b2c5a-1693-4e67-96d5-197e1fdc86943
403975alosetron 0.5 MG Oral TabletSCDd62b2c5a-1693-4e67-96d5-197e1fdc86943
259306alosetron 1 MG Oral TabletSCDd62b2c5a-1693-4e67-96d5-197e1fdc86943
403975alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral TabletSYd62b2c5a-1693-4e67-96d5-197e1fdc86943
259306alosetron 1 MG (as alosetron HCl 1.124 MG) Oral TabletSYd62b2c5a-1693-4e67-96d5-197e1fdc86943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71930-011-307193000113030 TABLET in 1 BOTTLE (71930-011-30) 30 tablet2019-02-01NoNoHistorical