Alosetron

Product NDC
70756-702
11-digit product format
707560702
Labeler code
70756
Product ID
70756-702_6e1e5a99-5018-42e7-8e2c-bcd0ac1e80fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alosetron
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alosetron
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
70756-702-30Alosetron30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-702ALOSETRON TABLET [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 1 package rows20220324_2846a244-7540-442b-81bc-638e641497ce.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
403975alosetron HCl 0.5 MG Oral TabletPSN2846a244-7540-442b-81bc-638e641497ce5
259306alosetron HCl 1 MG Oral TabletPSN2846a244-7540-442b-81bc-638e641497ce5
403975alosetron 0.5 MG Oral TabletSCD2846a244-7540-442b-81bc-638e641497ce5
259306alosetron 1 MG Oral TabletSCD2846a244-7540-442b-81bc-638e641497ce5
403975alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral TabletSY2846a244-7540-442b-81bc-638e641497ce5
259306alosetron 1 MG (as alosetron HCl 1.124 MG) Oral TabletSY2846a244-7540-442b-81bc-638e641497ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-702-307075607023030 TABLET in 1 BOTTLE (70756-702-30) 30 tablet2020-09-140000-00-00NoNoCurrent