Home NDC 43598-505 Raloxifene hydrochloride
Product NDC 43598-505
11-digit product format 435980505
Labeler code 43598
Product ID 43598-505_f08636b3-11f2-23f1-e053-2a95a90a12e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr.Reddy�s Laboratories Inc
Application ANDA206384
Marketing category ANDA
Marketing start 2016-10-12
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 A206384-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206384-001 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 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206384-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-10-12 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 43598-505-01 Raloxifene hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 5 43598-505-10 Raloxifene hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 5 43598-505-30 Raloxifene hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-505 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY’S LABORATORIES INC] 5 Current NDC, Legacy NDC, 3 package rows 20221224_8f24455c-34dc-4e07-bcd3-24326b9cc377.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE Major Pharmaceuticals e2967d3c-238c-40cf-b3d8-89482a502928 2025-03-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206384 application number: ANDA206384 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE Bryant Ranch Prepack ad3ef791-ac90-4f66-8da6-95b31e4c3eb6 2023-03-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206384 application number: ANDA206384 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE ScieGen Pharmaceuticals Inc 8152e68b-61a8-4897-8e03-900135b1dbd5 2023-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206384 application number: ANDA206384 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE Dr.Reddys Laboratories Inc 8f24455c-34dc-4e07-bcd3-24326b9cc377 2022-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206384 application number: ANDA206384 ndc (product): 43598-505 Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 6fd63a06-5bc5-4c50-9b85-b09c89100b80 2018-04-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206384 application number: ANDA206384
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 43598-505-01 43598050501 100 TABLET, FILM COATED in 1 BOTTLE (43598-505-01) 2016-10-12 0000-00-00 No No Current 43598-505-10 43598050510 1000 TABLET, FILM COATED in 1 BOTTLE (43598-505-10) 2016-10-12 0000-00-00 No No Current 43598-505-30 43598050530 30 TABLET, FILM COATED in 1 BOTTLE (43598-505-30) 2016-10-12 0000-00-00 No No Current