FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
71335-1663
11-digit product format
713351663
Labeler code
71335
Product ID
71335-1663_ac4f5eb7-441c-4b01-bbce-71d5c118bfa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090842
Marketing category
ANDA
Marketing start
2016-06-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1663IInactivated by FDA2026-07-31
excluded packagepackage71335-166371335-1663-1IInactivated by FDA2026-07-31
excluded packagepackage71335-166371335-1663-2IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090842-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090842-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090842-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENEAmerican Health Packagingf5c25553-1546-451d-8069-c0f484c477412024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENEAphena Pharma Solutions - Tennessee, LLC53a2db10-4af8-4032-b598-b7c7a09698012021-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEExelan Pharmaceuticals, Inc.2b94ecf5-d870-4132-b455-d5ee5c9dce562020-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENECipla USA Inc.8fef5bfd-a786-4442-b09b-f3b81812cdac2020-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1663-12024-01-30C16284748780-11030e365-05ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
71335-1663-22024-01-30C16284748780-11030e365-05ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1663-1Raloxifene Hydrochloride60 in 1 BOTTLETABLET602
71335-1663-2Raloxifene Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1663RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [BRYANT RANCH PREPACK]2Legacy NDC, 2 package rows20221202_ae557c81-e206-47fd-881e-b8f7fca2a3b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNae557c81-e206-47fd-881e-b8f7fca2a3b02
1490065raloxifene hydrochloride 60 MG Oral TabletSCDae557c81-e206-47fd-881e-b8f7fca2a3b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1663-17133516630160 TABLET in 1 BOTTLE (71335-1663-1) 60 tablet2020-07-150000-00-00NoNoCurrent
71335-1663-27133516630230 TABLET in 1 BOTTLE (71335-1663-2) 30 tablet2020-07-150000-00-00NoNoCurrent