FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
65162-057
11-digit product format
651620057
Labeler code
65162
Product ID
65162-057_6c80d57b-e265-43cb-a781-6299ea73dccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA208206
Marketing category
ANDA
Marketing start
2016-01-20
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
2027-12-31
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
A208206-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208206-001AB

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 22:54:322026-06A208206-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2016-04-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208206-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAmneal Pharmaceuticals LLC3798c70b-a4b0-4811-9788-e4c9cff47ebe2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208206
application number: ANDA208206
ndc (product): 65162-057
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAvPAK6f7eb934-aa60-51e1-e053-2a91aa0a39142026-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208206
application number: ANDA208206

Additional Listing Data#

Finished product
Yes
Brand name base
Raloxifene Hydrochloride
Listing expiration
2027-12-31

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
3798c70b-a4b0-4811-9788-e4c9cff47ebeAvailable 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
65162-057-03Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3016
65162-057-09Raloxifene Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016
65162-057-10Raloxifene Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10016
65162-057-11Raloxifene Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100016
65162-057-33Raloxifene Hydrochloride2000 in 1 BOTTLETABLET, FILM COATED200016
65162-057-50Raloxifene Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-057-03EA - Each65162-057ac8f56b9-3780-46d8-8aad-693ad56eba9e12016-07-19
65162-057-09EA - Each65162-057629dd3d5-e63d-496f-b7df-d5ad605eaa4512016-07-19
65162-057-10EA - Each65162-0571344393d-b4ca-4b4b-a52e-33060dd7cf9f12016-09-02
65162-057-11EA - Each65162-057be52925b-f65d-4b2b-bce1-fcd72f0eeea712016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-057RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 6 package rows20241218_3798c70b-a4b0-4811-9788-e4c9cff47ebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN3798c70b-a4b0-4811-9788-e4c9cff47ebe16
1490065raloxifene hydrochloride 60 MG Oral TabletSCD3798c70b-a4b0-4811-9788-e4c9cff47ebe16
1490065raloxifene HCl 60 MG Oral TabletPSN6f7eb934-aa60-51e1-e053-2a91aa0a39146
1490065raloxifene hydrochloride 60 MG Oral TabletSCD6f7eb934-aa60-51e1-e053-2a91aa0a39146
1490065raloxifene HCl 60 MG Oral TabletPSN5a65cd5b-0f9e-46ac-ae01-8b2223186c414
1490065raloxifene hydrochloride 60 MG Oral TabletSCD5a65cd5b-0f9e-46ac-ae01-8b2223186c414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-057-036516200570330 TABLET, FILM COATED in 1 BOTTLE (65162-057-03) 2016-01-200000-00-00NoNoCurrent
65162-057-096516200570990 TABLET, FILM COATED in 1 BOTTLE (65162-057-09) 2016-01-200000-00-00NoNoCurrent
65162-057-1065162005710100 TABLET, FILM COATED in 1 BOTTLE (65162-057-10) 2016-01-200000-00-00NoNoCurrent
65162-057-11651620057111000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11) 2016-01-200000-00-00NoNoCurrent
65162-057-33651620057332000 TABLET, FILM COATED in 1 BOTTLE (65162-057-33) 2016-01-200000-00-00NoNoCurrent
65162-057-5065162005750500 TABLET, FILM COATED in 1 BOTTLE (65162-057-50) 2016-01-200000-00-00NoNoCurrent