Home NDC 63629-7708-1 Raloxifene Hydrochloride
Product NDC 63629-7708
Requested package NDC 63629-7708-1
11-digit product format 636297708
Labeler code 63629
Product ID 63629-7708_29a280c3-008f-440b-9fa4-0f514342e3bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090842
Marketing category ANDA
Marketing start 2016-06-29
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 2021-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090842-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090842-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A090842-001 AB 1 a50c72e98297…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Raloxifene Hydrochloride RALOXIFENE American Health Packaging f5c25553-1546-451d-8069-c0f484c47741 2024-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE Aphena Pharma Solutions - Tennessee, LLC 53a2db10-4af8-4032-b598-b7c7a0969801 2021-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE HYDROCHLORIDE Exelan Pharmaceuticals, Inc. 2b94ecf5-d870-4132-b455-d5ee5c9dce56 2020-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE Cipla USA Inc. 8fef5bfd-a786-4442-b09b-f3b81812cdac 2020-09-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 63629-7708-1 2020-10-14 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-2 2020-10-14 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-3 2020-10-14 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-4 2020-10-14 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-5 2020-10-14 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-1 2020-01-31 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-2 2020-01-31 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-3 2020-01-31 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-4 2020-01-31 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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 63629-7708-5 2020-01-31 C162847 48780-1 9d75b9d0-e791-f424-e053-dadaa90a57ce These 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-7708-1 63629770801 30 TABLET in 1 BOTTLE (63629-7708-1) 30 tablet 2018-07-02 0000-00-00 No No Current