FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
66993-661
Requested package NDC
66993-661-30
11-digit product format
669930661
Labeler code
66993
Product ID
66993-661_d720873a-8c64-4be0-b47a-09ea0f076248
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
ANDA204310
Marketing category
ANDA
Marketing start
2015-08-28
Marketing end
2022-07-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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
excluded packagepackage66993-66166993-661-30DDiscontinued by firm2026-08-03

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-661-02EA - Each66993-6614580fac4-a3c5-4c7b-a2fe-0cc71254e86412016-01-13
66993-661-30EA - Each66993-6617bf4bc9a-cba3-4c6b-8839-7ad3ec3b52b712016-01-13
66993-661-88EA - Each66993-661d8ae8757-8731-4dfe-89e0-ba981ae7262e12015-11-12

DailyMed Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-661-306699306613030 TABLET, FILM COATED in 1 BOTTLE (66993-661-30) 2015-08-282022-07-31NoNoCurrent