FDA.reportPublic FDA data

Raloxifene hydrochloride

Product NDC
71610-053
11-digit product format
716100053
Labeler code
71610
Product ID
71610-053_29e0719a-c1c4-429b-8544-f1efe06c33fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA206384
Marketing category
ANDA
Marketing start
2016-10-12
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
A206384-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206384-001AB

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 22:54:322026-06A206384-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-10-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206384-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEMajor Pharmaceuticalse2967d3c-238c-40cf-b3d8-89482a5029282025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepackad3ef791-ac90-4f66-8da6-95b31e4c3eb62023-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEScieGen Pharmaceuticals Inc8152e68b-61a8-4897-8e03-900135b1dbd52023-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEDr.Reddys Laboratories Inc8f24455c-34dc-4e07-bcd3-24326b9cc3772022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC6fd63a06-5bc5-4c50-9b85-b09c89100b802018-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206384
application number: ANDA206384
ndc (product): 71610-053

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
6fd63a06-5bc5-4c50-9b85-b09c89100b80Available 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
71610-053-60Raloxifene hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-053-60EA - Each71610-053ecdfbbd3-27c7-4979-b8c3-91aa3f33db1212018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-053RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20180503_6fd63a06-5bc5-4c50-9b85-b09c89100b80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN6fd63a06-5bc5-4c50-9b85-b09c89100b801
1490065raloxifene hydrochloride 60 MG Oral TabletSCD6fd63a06-5bc5-4c50-9b85-b09c89100b801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-053-607161000536090 TABLET, FILM COATED in 1 BOTTLE (71610-053-60) 2018-04-260000-00-00NoNoCurrent