FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
0440-5295
11-digit product format
004405295
Labeler code
0440
Product ID
0440-5295_3a9a9dae-0c0a-465f-887a-bd7454e4c79c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA090842
Marketing category
ANDA
Marketing start
2014-11-12
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
E
Listing certified through
2018-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-5295IInactivated by FDA2026-07-31
excluded packagepackage0440-52950440-5295-01IInactivated by FDA2026-07-31
excluded packagepackage0440-52950440-5295-05IInactivated by FDA2026-07-31
excluded packagepackage0440-52950440-5295-30IInactivated by FDA2026-07-31
excluded packagepackage0440-52950440-5295-60IInactivated by FDA2026-07-31
excluded packagepackage0440-52950440-5295-81IInactivated by FDA2026-07-31
excluded packagepackage0440-52950440-5295-90IInactivated 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
0440-5295-012020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese 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
0440-5295-052020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese 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
0440-5295-302020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese 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
0440-5295-602020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese 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
0440-5295-812020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese 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
0440-5295-902020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese 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
0440-5295-01Raloxifene Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
0440-5295-05Raloxifene Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
0440-5295-30Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
0440-5295-60Raloxifene Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
0440-5295-81Raloxifene Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3002
0440-5295-90Raloxifene Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5295-05EA - Each0440-529538163895-790e-4b41-8f1b-ad549ef1cd4112017-08-11
0440-5295-30EA - Each0440-5295d7e80340-aa20-4051-a1c5-f877529630af12017-08-11
0440-5295-60EA - Each0440-52954bcb3859-54ac-4ab6-b8d4-4f9fc604c1fa12017-08-11
0440-5295-81EA - Each0440-52958daf2f69-12ff-4b0c-96e8-f1a4493f82b312018-04-19
0440-5295-90EA - Each0440-529518d24795-bd09-4225-bb13-2712357c4b7412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5295RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 6 package rows20161019_c9b60ef1-c88b-4363-9a28-5854b7ff8a50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNc9b60ef1-c88b-4363-9a28-5854b7ff8a502
1490065raloxifene hydrochloride 60 MG Oral TabletSCDc9b60ef1-c88b-4363-9a28-5854b7ff8a502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-5295-0100440529501100 in 1 BOTTLEHistorical
0440-5295-0500440529505500 in 1 BOTTLEHistorical
0440-5295-300044052953030 in 1 BOTTLEHistorical
0440-5295-600044052956060 in 1 BOTTLEHistorical
0440-5295-8100440529581300 in 1 BOTTLEHistorical
0440-5295-900044052959090 in 1 BOTTLEHistorical