FDA.reportPublic FDA data

Evista

Product NDC
0002-4184
11-digit product format
000024184
Labeler code
0002
Product ID
0002-4184_d46edd04-2907-438c-9e1f-b94b5509c0fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA020815
Marketing category
NDA
Marketing start
1998-01-06
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
N020815-001EVISTARALOXIFENE HYDROCHLORIDE60MGTABLET / ORALABRLD, RS1997-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020815-001AB

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 22:54:322026-06N020815-001EVISTA60MGTABLET / ORALABRLD, RS1997-12-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020815-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EvistaRALOXIFENE HYDROCHLORIDEEli Lilly and Companyfcaaa6dc-74e8-4fb8-800c-5574bf0f8de92025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020815
application number: NDA020815
ndc (product): 0002-4184

Additional Listing Data#

Finished product
Yes
Brand name base
Evista
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1490065Internal RxNorm lookup
1490067Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
7ad62b49-6132-2a8c-4edd-73f39b2bf45cProduct name620210312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-4184-30Evista30 in 1 BOTTLETABLET3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-4184-02EA - Each0002-41841ba4d729-941c-4916-a2a0-4da427f10f5a12017-06-15
0002-4184-07EA - Each0002-4184b1b5cc29-1ad5-45ae-9063-fda79d9ae2e112017-06-15
0002-4184-30EA - Each0002-4184cd4d89a2-e0aa-4a47-9e60-ce0dc988efa112017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Raloxifene hydrochlorideACTIVE INGREDIENT4F86W47BR6EVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
RaloxifeneACTIVE MOIETYYX9162EO3IEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
CrospovidoneINACTIVE INGREDIENT68401960MKEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
HypromellosesINACTIVE INGREDIENT3NXW29V3WOEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Magnesium stearateINACTIVE INGREDIENT70097M6I30EVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
PovidoneINACTIVE INGREDIENTFZ989GH94EEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3EVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPEVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-4184EVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY]30Current NDC, Legacy NDC, 1 package rows20241206_fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490067Evista 60 MG Oral TabletPSNfcaaa6dc-74e8-4fb8-800c-5574bf0f8de931
1490065raloxifene HCl 60 MG Oral TabletPSNfcaaa6dc-74e8-4fb8-800c-5574bf0f8de931
1490067raloxifene hydrochloride 60 MG Oral Tablet [Evista]SBDfcaaa6dc-74e8-4fb8-800c-5574bf0f8de931
1490065raloxifene hydrochloride 60 MG Oral TabletSCDfcaaa6dc-74e8-4fb8-800c-5574bf0f8de931
1490067Evista 60 MG Oral TabletSYfcaaa6dc-74e8-4fb8-800c-5574bf0f8de931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-4184-0200002418402100 TABLET in 1 BOTTLE (0002-4184-02) 100 tablet2016-12-160000-00-00NoNoCurrent
0002-4184-300000241843030 TABLET in 1 BOTTLE (0002-4184-30) 30 tablet2016-12-160000-00-00NoNoCurrent