Home NDC 50268-694 Raloxifene Hydrochloride
Product NDC 50268-694
11-digit product format 502680694
Labeler code 50268
Product ID 50268-694_48255cf3-7607-03f0-e063-6394a90ae486
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvPAK
Application ANDA208206
Marketing category ANDA
Marketing start 2018-06-27
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 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208206-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208206-001 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 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 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 A208206-001 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Raloxifene Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RALOXIFENE HYDROCHLORIDE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4F86W47BR6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1490065 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50268-694-15 2022-02-01 C162847 48780-1 d6a99b39-36d4-a426-e053-dadaa90af4c2 Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 50268-694-15 2022-02-01 C162847 48780-1 d6a99b39-36d4-a426-e053-dadaa90af4c2 Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 50268-694-15 2022-01-28 C162847 48780-1 d6a99b39-36d4-a426-e053-dadaa90af4c2 Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 50268-694-15 2022-01-28 C162847 48780-1 d6a99b39-36d4-a426-e053-dadaa90af4c2 Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50268-694-11 Raloxifene Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 50268-694-15 Raloxifene Hydrochloride 50 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-694 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AVPAK] 4 Current NDC, Legacy NDC, 2 package rows 20240110_6f7eb934-aa60-51e1-e053-2a91aa0a3914.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-694-11 50268069411 1 in 1 BLISTER PACK Historical 50268-694-15 50268069415 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11) 50 blister pack 2018-06-27 0000-00-00 No No Current