FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
69097-825
11-digit product format
690970825
Labeler code
69097
Product ID
69097-825_ebab2c47-9350-447a-9372-7ade623d5bb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090842
Marketing category
ANDA
Marketing start
2016-06-29
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
Raloxifene HydrochlorideRALOXIFENECipla USA Inc.8fef5bfd-a786-4442-b09b-f3b81812cdac2020-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
ndc (product): 69097-825

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
8fef5bfd-a786-4442-b09b-f3b81812cdacAvailable 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
69097-825-02Raloxifene Hydrochloride30 in 1 BOTTLETABLET304
69097-825-07Raloxifene Hydrochloride100 in 1 BOTTLETABLET1004
69097-825-15Raloxifene Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-825-02EA - Each69097-8251d797514-c2f2-4bcc-871b-746d5f6f852f12016-07-19
69097-825-07EA - Each69097-82569c05953-9d94-469a-80df-99ecb9d1113912016-07-19
69097-825-15EA - Each69097-8255daae9d7-2877-463d-8749-40bd3fa7992812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-825RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [CIPLA USA INC.]4Current NDC, Legacy NDC, 3 package rows20201001_8fef5bfd-a786-4442-b09b-f3b81812cdac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNf5c25553-1546-451d-8069-c0f484c477418
1490065raloxifene hydrochloride 60 MG Oral TabletSCDf5c25553-1546-451d-8069-c0f484c477418
1490065raloxifene HCl 60 MG Oral TabletPSN8fef5bfd-a786-4442-b09b-f3b81812cdac4
1490065raloxifene hydrochloride 60 MG Oral TabletSCD8fef5bfd-a786-4442-b09b-f3b81812cdac4
1490065raloxifene HCl 60 MG Oral TabletPSNae557c81-e206-47fd-881e-b8f7fca2a3b02
1490065raloxifene hydrochloride 60 MG Oral TabletSCDae557c81-e206-47fd-881e-b8f7fca2a3b02
1490065raloxifene HCl 60 MG Oral TabletPSN35b5e3e5-0dfe-4abe-a928-d91dedd450e11
1490065raloxifene HCl 60 MG Oral TabletPSN53a2db10-4af8-4032-b598-b7c7a09698011
1490065raloxifene hydrochloride 60 MG Oral TabletSCD35b5e3e5-0dfe-4abe-a928-d91dedd450e11
1490065raloxifene hydrochloride 60 MG Oral TabletSCD53a2db10-4af8-4032-b598-b7c7a09698011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-825-026909708250230 TABLET in 1 BOTTLE (69097-825-02) 30 tablet2016-06-290000-00-00NoNoCurrent
69097-825-0769097082507100 TABLET in 1 BOTTLE (69097-825-07) 100 tablet2016-06-290000-00-00NoNoCurrent
69097-825-15690970825151000 TABLET in 1 BOTTLE (69097-825-15) 1000 tablet2016-06-290000-00-00NoNoCurrent