FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
42291-726
Requested package NDC
42291-726-10
11-digit product format
422910726
Labeler code
42291
Product ID
42291-726_d5bfa252-db5b-6955-e053-2995a90a6012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA078193
Marketing category
ANDA
Marketing start
2014-11-03
Marketing end
0000-00-00
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
2023-12-31
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 packagepackage42291-72642291-726-10DDiscontinued by firm2026-07-31

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
A078193-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078193-001AB

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 22:54:322026-06A078193-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-03-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078193-001AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepack3568ed3c-6afd-4872-a861-93a7873bec9c2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078193
application number: ANDA078193
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e6be5b1d-757d-4bab-ad6a-c421960a104d2021-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078193
application number: ANDA078193

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-726-10EA - Each42291-726aaf4be36-a9e5-402d-933b-6d5d013a7b5912014-12-01
42291-726-90EA - Each42291-726987a6115-5965-4bcf-9503-34cf5868d6b512014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALOXIFENE HYDROCHLORIDEACTIVE INGREDIENT4F86W47BR6RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
RALOXIFENEACTIVE MOIETYYX9162EO3IRALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WRALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XRALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-726-10422910726101000 TABLET, FILM COATED in 1 BOTTLE (42291-726-10) 2014-11-030000-00-00NoNoCurrent