FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
31722-256
11-digit product format
317220256
Labeler code
31722
Product ID
31722-256_46a8448f-fd60-4043-ae6a-512d67d50cc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals Inc
Application
ANDA090842
Marketing category
ANDA
Marketing start
2014-09-24
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
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct31722-256DDiscontinued by firm2026-07-31
excluded packagepackage31722-25631722-256-01DDiscontinued by firm2026-07-31
excluded packagepackage31722-25631722-256-10DDiscontinued by firm2026-07-31
excluded packagepackage31722-25631722-256-30DDiscontinued 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
A090842-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090842-001AB

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 22:54:322026-06A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090842-001AB1a50c72e98297…

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 HydrochlorideRALOXIFENEAmerican Health Packagingf5c25553-1546-451d-8069-c0f484c477412024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENEAphena Pharma Solutions - Tennessee, LLC53a2db10-4af8-4032-b598-b7c7a09698012021-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEExelan Pharmaceuticals, Inc.2b94ecf5-d870-4132-b455-d5ee5c9dce562020-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENECipla USA Inc.8fef5bfd-a786-4442-b09b-f3b81812cdac2020-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-256-012025-06-17C16284748780-19855e2a2-3270-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-102025-06-17C16284748780-19855e2a2-3270-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-302025-06-17C16284748780-19855e2a2-3270-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-012019-11-27C16284748780-19855e2a2-3270-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-102019-11-27C16284748780-19855e2a2-3270-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-302019-11-27C16284748780-19855e2a2-3270-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-256-01EA - Each31722-25601b25acd-0db2-4ac9-9af9-0207af2376da12014-10-03
31722-256-10EA - Each31722-25683e267ab-46bf-4293-a28b-9766a6854a7f12014-10-03
31722-256-30EA - Each31722-25600a536fc-b42f-43f6-b010-804470adfa5a12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALOXIFENE HYDROCHLORIDEACTIVE INGREDIENT4F86W47BR6RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
RALOXIFENEACTIVE MOIETYYX9162EO3IRALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PRALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ARALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-256RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]1Legacy NDC20140925_8f4fe353-c5de-44ba-9c68-b75a185f7dc5.zip