Home NDC 65862-709 Raloxifene Hydrochloride
Product NDC 65862-709
11-digit product format 658620709
Labeler code 65862
Product ID 65862-709_161df518-c043-4476-968b-d0268ae03fd5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-709 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 65862-709 65862-709-39 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-709-39 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-709-39 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-709-39 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-709-39 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-709-39 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-709-39 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-709-39 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-709-39 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-709-39 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-709-39 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-709-39 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-709-39 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-709-39 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-709-39 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-709-39 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-709-39 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-709-39 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-709-39 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-709-39 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-709-39 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 65862-709-39 5b2001dcd8f5…54b53d4dc9e4…
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 65862-709-01 Raloxifene Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 7 65862-709-03 Raloxifene Hydrochloride 3 in 1 CARTON TABLET, FILM COATED 3 7 65862-709-10 Raloxifene Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 65862-709-22 Raloxifene Hydrochloride 2000 in 1 BOTTLE TABLET, FILM COATED 2000 7 65862-709-30 Raloxifene Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 7 65862-709-99 Raloxifene Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RALOXIFENE HYDROCHLORIDE ACTIVE INGREDIENT 4F86W47BR6 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 RALOXIFENE ACTIVE MOIETY YX9162EO3I RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-709 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20240220_e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5.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 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 ndc (product): 65862-709
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65862-709-01 65862070901 100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01) 2015-08-28 0000-00-00 No No Current 65862-709-03 65862070903 3 BLISTER PACK in 1 CARTON (65862-709-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10) 3 blister pack 2015-08-28 0000-00-00 No No Current 65862-709-10 65862070910 10 in 1 BLISTER PACK Historical 65862-709-22 65862070922 2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22) 2015-08-28 0000-00-00 No No Current 65862-709-30 65862070930 30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30) 2015-08-28 0000-00-00 No No Current 65862-709-39 65862070939 3000 TABLET, FILM COATED in 1 BAG (65862-709-39) 28-AUG-15 Current 65862-709-99 65862070999 1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99) 2015-08-28 0000-00-00 No No Current