FDA.reportPublic FDA data

Raloxifene hydrochloride

Product NDC
72241-010
11-digit product format
722410010
Labeler code
72241
Product ID
72241-010_f0db29f5-28da-4165-94f8-24727b6b71e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA211324
Marketing category
ANDA
Marketing start
2017-12-30
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
72241-010-05Raloxifene hydrochloride100 in 1 BOTTLETABLET, COATED1001
72241-010-11Raloxifene hydrochloride1000 in 1 BOTTLETABLET, COATED10001
72241-010-13Raloxifene hydrochloride2000 in 1 BOTTLETABLET, COATED20001
72241-010-22Raloxifene hydrochloride30 in 1 BOTTLETABLET, COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-010-05EA - Each72241-01056a77f35-79c9-4edb-9496-7df88d642bb512022-10-06
72241-010-11EA - Each72241-010999327f1-2b8e-4d64-9c64-5a2136b7cfec12022-09-12
72241-010-22EA - Each72241-0106203a440-bb05-42ae-a767-d9916d03246712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-010RALOXIFENE HYDROCHLORIDE TABLET, COATED [MODAVAR PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 4 package rows20220120_f0db29f5-28da-4165-94f8-24727b6b71e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN7e4bfee5-fefc-4115-9bdb-222eccefca83100
1490065raloxifene hydrochloride 60 MG Oral TabletSCD7e4bfee5-fefc-4115-9bdb-222eccefca83100
1490065raloxifene HCl 60 MG Oral TabletPSN22a951ee-2ffc-4c60-b681-0f80285153e14
1490065raloxifene hydrochloride 60 MG Oral TabletSCD22a951ee-2ffc-4c60-b681-0f80285153e14
1490065raloxifene HCl 60 MG Oral TabletPSNf0db29f5-28da-4165-94f8-24727b6b71e51
1490065raloxifene hydrochloride 60 MG Oral TabletSCDf0db29f5-28da-4165-94f8-24727b6b71e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72241-010-0572241001005100 TABLET, COATED in 1 BOTTLE (72241-010-05) 2017-12-300000-00-00NoNoCurrent
72241-010-11722410010111000 TABLET, COATED in 1 BOTTLE (72241-010-11) 2017-12-300000-00-00NoNoCurrent
72241-010-13722410010132000 TABLET, COATED in 1 BOTTLE (72241-010-13) 2017-12-300000-00-00NoNoCurrent
72241-010-227224100102230 TABLET, COATED in 1 BOTTLE (72241-010-22) 2017-12-300000-00-00NoNoCurrent