FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
71610-504
11-digit product format
716100504
Labeler code
71610
Product ID
71610-504_b45bcef3-7e7d-4e6e-b181-80f89126bce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078193
Marketing category
ANDA
Marketing start
2014-03-28
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
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71610-504IInactivated by FDA2026-07-31
excluded packagepackage71610-50471610-504-60IInactivated 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
A078193-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078193-001AB

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 22:54:322026-06A078193-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-03-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078193-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack3568ed3c-6afd-4872-a861-93a7873bec9c2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078193
application number: ANDA078193
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e6be5b1d-757d-4bab-ad6a-c421960a104d2021-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078193
application number: ANDA078193

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
71610-504-602023-01-30C16284748780-1f386c64a-461c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-504-60Raloxifene Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-504-60EA - Each71610-50431330ffa-4e6b-4a05-93cd-a1f75e905f9612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-504RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20210129_a5102b05-a7b3-4b48-9ed8-a398cce78ea9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNa5102b05-a7b3-4b48-9ed8-a398cce78ea91
1490065raloxifene hydrochloride 60 MG Oral TabletSCDa5102b05-a7b3-4b48-9ed8-a398cce78ea91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-504-607161005046090 TABLET, FILM COATED in 1 BOTTLE (71610-504-60) 2020-12-140000-00-00NoNoCurrent