Raloxifene Hydrochloride

Product NDC
71335-2059
11-digit product format
713352059
Labeler code
71335
Product ID
71335-2059_7a2ab3a6-eba9-4ac6-ba53-3940b614102d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204310
Marketing category
ANDA
Marketing start
2015-08-28
Substance
RALOXIFENE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RALOXIFENE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4F86W47BR6
Rxcui1490065

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7ad62b49-6132-2a8c-4edd-73f39b2bf45cProduct name620210312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2059-1Raloxifene Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-2059-2Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2059RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240423_5a22ae27-1c55-487b-8e93-8ef1cec87065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN5a22ae27-1c55-487b-8e93-8ef1cec87065102
1490065raloxifene hydrochloride 60 MG Oral TabletSCD5a22ae27-1c55-487b-8e93-8ef1cec87065102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2059-17133520590160 TABLET, FILM COATED in 1 BOTTLE (71335-2059-1) 2022-03-030000-00-00NoNoCurrent
71335-2059-27133520590230 TABLET, FILM COATED in 1 BOTTLE (71335-2059-2) 2024-02-270000-00-00NoNoCurrent