Home NDC 65162-057-09 Raloxifene Hydrochloride
Product NDC 65162-057
Requested package NDC 65162-057-09
11-digit product format 651620057
Labeler code 65162
Product ID 65162-057_6c80d57b-e265-43cb-a781-6299ea73dccf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA208206
Marketing category ANDA
Marketing start 2016-01-20
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 2027-12-31
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 A208206-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208206-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208206-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-04-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Raloxifene Hydrochloride
Listing expiration 2027-12-31 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 65162-057-03 Raloxifene Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 16 65162-057-09 Raloxifene Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 16 65162-057-10 Raloxifene Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 16 65162-057-11 Raloxifene Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 16 65162-057-33 Raloxifene Hydrochloride 2000 in 1 BOTTLE TABLET, FILM COATED 2000 16 65162-057-50 Raloxifene Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-057 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 15 Current NDC, Legacy NDC, 6 package rows 20241218_3798c70b-a4b0-4811-9788-e4c9cff47ebe.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 · 2 matching rows.
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 65162-057-09 65162005709 90 TABLET, FILM COATED in 1 BOTTLE (65162-057-09) 2016-01-20 0000-00-00 No No Current