Alosetron

Product NDC
63629-2518
11-digit product format
636292518
Labeler code
63629
Product ID
63629-2518_cd337c95-1e5a-4dfa-84f7-e668c93d8565
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
1 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 HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2F5R1A46YW
Rxcui259306

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
63629-2518-1Alosetron30 in 1 BOTTLETABLET30103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2518ALOSETRON TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240112_38f5341f-5ae3-46bf-8bfc-30dff2068477.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259306alosetron HCl 1 MG Oral TabletPSN38f5341f-5ae3-46bf-8bfc-30dff2068477103
259306alosetron 1 MG Oral TabletSCD38f5341f-5ae3-46bf-8bfc-30dff2068477103
259306alosetron 1 MG (as alosetron HCl 1.124 MG) Oral TabletSY38f5341f-5ae3-46bf-8bfc-30dff2068477103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2518-16362925180130 TABLET in 1 BOTTLE (63629-2518-1) 30 tablet2021-03-290000-00-00NoNoCurrent