Home NDC 71335-1715 Raloxifene Hydrochloride
Product NDC 71335-1715
11-digit product format 713351715
Labeler code 71335
Product ID 71335-1715_8f53d830-2fb0-400c-8f03-f81858280782
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078193
Marketing category ANDA
Marketing start 2014-03-28
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 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 A078193-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078193-001 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 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 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 71335-1715-1 Raloxifene Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 102 71335-1715-2 Raloxifene Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1715 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 2 package rows 20231024_3568ed3c-6afd-4872-a861-93a7873bec9c.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 71335-1715-1 71335171501 60 TABLET, FILM COATED in 1 BOTTLE (71335-1715-1) 2020-10-02 0000-00-00 No No Current 71335-1715-2 71335171502 30 TABLET, FILM COATED in 1 BOTTLE (71335-1715-2) 2021-12-29 0000-00-00 No No Current