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 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 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 2026-08-18 06:07:40 2026-07 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211324-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-08-18 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 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
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