FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
65862-709
Requested package NDC
65862-709-39
11-digit product format
658620709
Labeler code
65862
Product ID
65862-709_161df518-c043-4476-968b-d0268ae03fd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-70965862-709-39UNFINISHEDActive or certified unfinished drug listing2026-07-31

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
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
ndc (product): 65862-709

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
e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5Available 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
65862-709-01Raloxifene Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
65862-709-03Raloxifene Hydrochloride3 in 1 CARTONTABLET, FILM COATED37
65862-709-10Raloxifene Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
65862-709-22Raloxifene Hydrochloride2000 in 1 BOTTLETABLET, FILM COATED20007
65862-709-30Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
65862-709-99Raloxifene Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-709-01EA - Each65862-7091fbb9680-3188-4851-90d6-5d0eeccf881f12021-05-05
65862-709-30EA - Each65862-709d5df931c-abb5-4c2a-8f3b-4340042bd16912021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALOXIFENE HYDROCHLORIDEACTIVE INGREDIENT4F86W47BR6RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
RALOXIFENEACTIVE MOIETYYX9162EO3IRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-709RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 6 package rows20240220_e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5.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
1490065raloxifene HCl 60 MG Oral TabletPSNe8b6cbe0-c1f4-4678-b852-f629a7f6a1b57
1490065raloxifene hydrochloride 60 MG Oral TabletSCDe8b6cbe0-c1f4-4678-b852-f629a7f6a1b57
1490065raloxifene HCl 60 MG Oral TabletPSN804e873e-f48b-4c25-ad7b-41d44f61bdde3
1490065raloxifene hydrochloride 60 MG Oral TabletSCD804e873e-f48b-4c25-ad7b-41d44f61bdde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-709-39658620709393000 TABLET, FILM COATED in 1 BAG (65862-709-39)28-AUG-15Current