Home NDC 16714-213 Raloxifene Hydrochloride
Product NDC 16714-213
11-digit product format 167140213
Labeler code 16714
Product ID 16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA204310
Marketing category ANDA
Marketing start 2015-08-28
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 A204310-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204310-001 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 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 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 A204310-001 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 A-S Medication Solutions 804e873e-f48b-4c25-ad7b-41d44f61bdde 2025-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204310 application number: ANDA204310 Raloxifene Hydrochloride RALOXIFENE HYDROCHLORIDE Bryant Ranch Prepack 5a22ae27-1c55-487b-8e93-8ef1cec87065 2024-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204310 application number: ANDA204310 Raloxifene Hydrochloride RALOXIFENE HYDROCHLORIDE NorthStar Rx LLC 0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf 2024-02-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204310 application number: ANDA204310 ndc (product): 16714-213 Raloxifene Hydrochloride RALOXIFENE HYDROCHLORIDE Aurobindo Pharma Limited e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5 2024-02-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204310 application number: ANDA204310
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 16714-213-01 Raloxifene Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3 16714-213-02 Raloxifene Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 3 16714-213-03 Raloxifene Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-213 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 3 Current NDC, Legacy NDC, 3 package rows 20240220_0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-213-01 16714021301 30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01) 2015-08-28 0000-00-00 No No Current 16714-213-02 16714021302 100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02) 2015-08-28 0000-00-00 No No Current 16714-213-03 16714021303 1000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03) 2015-08-28 0000-00-00 No No Current