FDA.reportPublic FDA data

Raloxifene hydrochloride

Product NDC
71209-082
11-digit product format
712090082
Labeler code
71209
Product ID
71209-082_14d4c334-b49d-4479-a91e-20b7276b4eca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA211324
Marketing category
ANDA
Marketing start
2017-12-30
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
A211324-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2020-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211324-001AB

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 22:54:322026-06A211324-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2020-08-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211324-001AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepack7e4bfee5-fefc-4115-9bdb-222eccefca832024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211324
application number: ANDA211324
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEA-S Medication Solutions22a951ee-2ffc-4c60-b681-0f80285153e12023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211324
application number: ANDA211324
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDECadila Pharmaceuticals Limiteda46bcc4f-f63d-4200-836d-a653a3c616db2022-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211324
application number: ANDA211324
ndc (product): 71209-082
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEModavar Pharmaceuticals LLCf0db29f5-28da-4165-94f8-24727b6b71e52022-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211324
application number: ANDA211324

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
a46bcc4f-f63d-4200-836d-a653a3c616dbAvailable 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
71209-082-01Raloxifene hydrochloride30 in 1 BOTTLETABLET, COATED305
71209-082-05Raloxifene hydrochloride100 in 1 BOTTLETABLET, COATED1005
71209-082-11Raloxifene hydrochloride1000 in 1 BOTTLETABLET, COATED10005
71209-082-13Raloxifene hydrochloride2000 in 1 BOTTLETABLET, COATED20005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-082RALOXIFENE HYDROCHLORIDE TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 4 package rows20220120_a46bcc4f-f63d-4200-836d-a653a3c616db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNa46bcc4f-f63d-4200-836d-a653a3c616db5
1490065raloxifene hydrochloride 60 MG Oral TabletSCDa46bcc4f-f63d-4200-836d-a653a3c616db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-082-017120900820130 TABLET, COATED in 1 BOTTLE (71209-082-01) 2017-12-300000-00-00NoNoCurrent
71209-082-0571209008205100 TABLET, COATED in 1 BOTTLE (71209-082-05) 2017-12-300000-00-00NoNoCurrent
71209-082-11712090082111000 TABLET, COATED in 1 BOTTLE (71209-082-11) 2021-12-130000-00-00NoNoCurrent
71209-082-13712090082132000 TABLET, COATED in 1 BOTTLE (71209-082-13) 2017-12-300000-00-00NoNoCurrent