Home NDC 72162-2418 Raloxifene hydrochloride
Product NDC 72162-2418
11-digit product format 721622418
Labeler code 72162
Product ID 72162-2418_098f2903-afc3-4a47-8c22-9cc1ce9d50c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA211324
Marketing category ANDA
Marketing start 2017-12-30
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 2026-12-31
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 A211324-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211324-001 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 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 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 A211324-001 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 HYDROCHLORIDE Bryant Ranch Prepack 7e4bfee5-fefc-4115-9bdb-222eccefca83 2024-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211324 application number: ANDA211324 ndc (product): 72162-2418 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE A-S Medication Solutions 22a951ee-2ffc-4c60-b681-0f80285153e1 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211324 application number: ANDA211324 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE Cadila Pharmaceuticals Limited a46bcc4f-f63d-4200-836d-a653a3c616db 2022-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211324 application number: ANDA211324 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE Modavar Pharmaceuticals LLC f0db29f5-28da-4165-94f8-24727b6b71e5 2022-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211324 application number: ANDA211324
Additional Listing Data#
Finished product Yes
Brand name base Raloxifene hydrochloride
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72162-2418-0 Raloxifene hydrochloride 1000 in 1 BOTTLE TABLET, COATED 1000 100 72162-2418-1 Raloxifene hydrochloride 100 in 1 BOTTLE TABLET, COATED 100 100 72162-2418-3 Raloxifene hydrochloride 30 in 1 BOTTLE TABLET, COATED 30 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2418 RALOXIFENE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK] 100 Current NDC, 3 package rows 20241102_7e4bfee5-fefc-4115-9bdb-222eccefca83.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-2418-0 72162241800 1000 TABLET, COATED in 1 BOTTLE (72162-2418-0) 2024-10-31 No No Current 72162-2418-1 72162241801 100 TABLET, COATED in 1 BOTTLE (72162-2418-1) 2024-10-31 No No Current 72162-2418-3 72162241803 30 TABLET, COATED in 1 BOTTLE (72162-2418-3) 2024-10-31 No No Current