FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
76282-256
11-digit product format
762820256
Labeler code
76282
Product ID
76282-256_7238f870-72f1-4e67-9c88-5125522971da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA090842
Marketing category
ANDA
Marketing start
2014-11-12
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

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
ndc (product): 76282-256
Raloxifene HydrochlorideRALOXIFENECipla USA Inc.8fef5bfd-a786-4442-b09b-f3b81812cdac2020-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4F86W47BR6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1490065Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b94ecf5-d870-4132-b455-d5ee5c9dce56Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7ad62b49-6132-2a8c-4edd-73f39b2bf45cProduct name620210312
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-256-01Raloxifene Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
76282-256-05Raloxifene Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
76282-256-10Raloxifene Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006
76282-256-30Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
76282-256-90Raloxifene Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-256-05EA - Each76282-25694547935-7aee-466c-bc1e-c2d95511f42d12015-10-02
76282-256-30EA - Each76282-25643165c4d-96f2-47ab-aa27-e025e0c9efb912014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALOXIFENE HYDROCHLORIDEACTIVE INGREDIENT4F86W47BR6RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
RALOXIFENEACTIVE MOIETYYX9162EO3IRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ARALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-256RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20201007_2b94ecf5-d870-4132-b455-d5ee5c9dce56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN2b94ecf5-d870-4132-b455-d5ee5c9dce566
1490065raloxifene hydrochloride 60 MG Oral TabletSCD2b94ecf5-d870-4132-b455-d5ee5c9dce566
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-256-0176282025601100 TABLET, FILM COATED in 1 BOTTLE (76282-256-01) 2014-11-120000-00-00NoNoCurrent
76282-256-0576282025605500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05) 2014-11-120000-00-00NoNoCurrent
76282-256-10762820256101000 TABLET, FILM COATED in 1 BOTTLE (76282-256-10) 2015-04-150000-00-00NoNoCurrent
76282-256-307628202563030 TABLET, FILM COATED in 1 BOTTLE (76282-256-30) 2014-11-120000-00-00NoNoCurrent
76282-256-907628202569090 TABLET, FILM COATED in 1 BOTTLE (76282-256-90) 2015-04-150000-00-00NoNoCurrent