Home NDC 50090-7073 Raloxifene Hydrochloride
Product NDC 50090-7073
11-digit product format 500907073
Labeler code 50090
Product ID 50090-7073_c6ae957a-83c9-442d-89b2-9febb63c82d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204310-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2015-08-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 50090-7073-1 Raloxifene Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7073 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20240124_804e873e-f48b-4c25-ad7b-41d44f61bdde.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 ndc (product): 50090-7073 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-7073-1 50090707301 90 TABLET, FILM COATED in 1 BOTTLE (50090-7073-1) 2024-01-23 No No Current