FDA.reportPublic FDA data

Raloxifene hydrochloride

Product NDC
50090-3363
Requested package NDC
50090-3363-1
11-digit product format
500903363
Labeler code
50090
Product ID
50090-3363_98e0318f-6b3a-4274-ae25-5bb9ee5b6bc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206384
Marketing category
ANDA
Marketing start
2016-10-12
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-336350090-3363-1IInactivated 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
A206384-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206384-001AB

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 22:54:322026-06A206384-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-10-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206384-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEMajor Pharmaceuticalse2967d3c-238c-40cf-b3d8-89482a5029282025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepackad3ef791-ac90-4f66-8da6-95b31e4c3eb62023-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEScieGen Pharmaceuticals Inc8152e68b-61a8-4897-8e03-900135b1dbd52023-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEDr.Reddys Laboratories Inc8f24455c-34dc-4e07-bcd3-24326b9cc3772022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC6fd63a06-5bc5-4c50-9b85-b09c89100b802018-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384

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
50090-3363-02023-01-30C16284748780-1f386c649-df21-0266-e053-dadaa90a7c1aThese 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
50090-3363-12023-01-30C16284748780-1f386c649-df21-0266-e053-dadaa90a7c1aThese 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
50090-3363-0Raloxifene hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
50090-3363-1Raloxifene hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3363-0EA - Each50090-336355e462d3-0386-4f1b-95e1-5dd0215603ec12019-05-02
50090-3363-1EA - Each50090-336322a9724b-7825-4461-a1b1-f21518758b4b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3363RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20190205_de746495-e92f-48c1-824e-56ca9401f2a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNde746495-e92f-48c1-824e-56ca9401f2a01
1490065raloxifene hydrochloride 60 MG Oral TabletSCDde746495-e92f-48c1-824e-56ca9401f2a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3363-15009033630190 TABLET, FILM COATED in 1 BOTTLE (50090-3363-1) 2018-03-290000-00-00NoNoCurrent