FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
71335-2059
11-digit product format
713352059
Labeler code
71335
Product ID
71335-2059_7a2ab3a6-eba9-4ac6-ba53-3940b614102d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204310
Marketing category
ANDA
Marketing start
2015-08-28
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
A204310-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2015-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204310-001AB

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 22:54:322026-06A204310-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2015-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204310-001AB1a50c72e98297…

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 HydrochlorideRALOXIFENE HYDROCHLORIDEA-S Medication Solutions804e873e-f48b-4c25-ad7b-41d44f61bdde2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack5a22ae27-1c55-487b-8e93-8ef1cec870652024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
ndc (product): 71335-2059
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDENorthStar Rx LLC0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf2024-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAurobindo Pharma Limitede8b6cbe0-c1f4-4678-b852-f629a7f6a1b52024-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310

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
5a22ae27-1c55-487b-8e93-8ef1cec87065Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2059-1Raloxifene Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-2059-2Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2059RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240423_5a22ae27-1c55-487b-8e93-8ef1cec87065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN5a22ae27-1c55-487b-8e93-8ef1cec87065102
1490065raloxifene hydrochloride 60 MG Oral TabletSCD5a22ae27-1c55-487b-8e93-8ef1cec87065102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2059-17133520590160 TABLET, FILM COATED in 1 BOTTLE (71335-2059-1) 2022-03-030000-00-00NoNoCurrent
71335-2059-27133520590230 TABLET, FILM COATED in 1 BOTTLE (71335-2059-2) 2024-02-270000-00-00NoNoCurrent