FDA.reportPublic FDA data

raloxifene hydrochloride

Product NDC
68462-393
11-digit product format
684620393
Labeler code
68462
Product ID
68462-393_3681932a-8ad0-4486-ae11-efc2f4b3ee96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
raloxifene hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA204491
Marketing category
ANDA
Marketing start
2016-03-22
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
A204491-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204491-001AB

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 22:54:322026-06A204491-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-03-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204491-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAc05521f8-95d2-44b8-8433-eba539c0f84c2024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204491
application number: ANDA204491
ndc (product): 68462-393

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
c05521f8-95d2-44b8-8433-eba539c0f84cAvailable 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
68462-393-01raloxifene hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
68462-393-10raloxifene hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007
68462-393-23raloxifene hydrochloride2000 in 1 BOTTLETABLET, FILM COATED20007
68462-393-30raloxifene hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
68462-393-90raloxifene hydrochloride90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-393-01EA - Each68462-39303418256-b780-402b-9d24-200bf413a3ca12016-05-16
68462-393-30EA - Each68462-3939760717c-81c4-4ba9-8d61-c48e7cbea87c12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-393RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, Legacy NDC, 5 package rows20241207_c05521f8-95d2-44b8-8433-eba539c0f84c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNc05521f8-95d2-44b8-8433-eba539c0f84c7
1490065raloxifene hydrochloride 60 MG Oral TabletSCDc05521f8-95d2-44b8-8433-eba539c0f84c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-393-0168462039301100 TABLET, FILM COATED in 1 BOTTLE (68462-393-01) 2016-03-22NoNoCurrent
68462-393-10684620393101000 TABLET, FILM COATED in 1 BOTTLE (68462-393-10) 2016-03-22NoNoCurrent
68462-393-23684620393232000 TABLET, FILM COATED in 1 BOTTLE (68462-393-23) 2016-03-22NoNoCurrent
68462-393-306846203933030 TABLET, FILM COATED in 1 BOTTLE (68462-393-30) 2016-03-22NoNoCurrent
68462-393-906846203939090 TABLET, FILM COATED in 1 BOTTLE (68462-393-90) 2016-03-22NoNoCurrent