Home NDC 68462-393 raloxifene hydrochloride
Product NDC 68462-393
11-digit product format 684620393
Labeler code 68462
Product ID 68462-393_3681932a-8ad0-4486-ae11-efc2f4b3ee96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name raloxifene hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA204491
Marketing category ANDA
Marketing start 2016-03-22
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A204491-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204491-001 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 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204491-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2016-03-22 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 68462-393-01 raloxifene hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 7 68462-393-10 raloxifene hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 68462-393-23 raloxifene hydrochloride 2000 in 1 BOTTLE TABLET, FILM COATED 2000 7 68462-393-30 raloxifene hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 7 68462-393-90 raloxifene hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-393 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 Current NDC, Legacy NDC, 5 package rows 20241207_c05521f8-95d2-44b8-8433-eba539c0f84c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68462-393-01 68462039301 100 TABLET, FILM COATED in 1 BOTTLE (68462-393-01) 2016-03-22 No No Current 68462-393-10 68462039310 1000 TABLET, FILM COATED in 1 BOTTLE (68462-393-10) 2016-03-22 No No Current 68462-393-23 68462039323 2000 TABLET, FILM COATED in 1 BOTTLE (68462-393-23) 2016-03-22 No No Current 68462-393-30 68462039330 30 TABLET, FILM COATED in 1 BOTTLE (68462-393-30) 2016-03-22 No No Current 68462-393-90 68462039390 90 TABLET, FILM COATED in 1 BOTTLE (68462-393-90) 2016-03-22 No No Current