Home NDC 76282-256 Raloxifene Hydrochloride
Product NDC 76282-256
11-digit product format 762820256
Labeler code 76282
Product ID 76282-256_7238f870-72f1-4e67-9c88-5125522971da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Exelan Pharmaceuticals, Inc.
Application ANDA090842
Marketing category ANDA
Marketing start 2014-11-12
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 A090842-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090842-001 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 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 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 76282-256-01 Raloxifene Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 6 76282-256-05 Raloxifene Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 6 76282-256-10 Raloxifene Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6 76282-256-30 Raloxifene Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 6 76282-256-90 Raloxifene Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 6
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 [EXELAN PHARMACEUTICALS, INC.] 1 RALOXIFENE ACTIVE MOIETY YX9162EO3I RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-256 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 5 package rows 20201007_2b94ecf5-d870-4132-b455-d5ee5c9dce56.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 American Health Packaging f5c25553-1546-451d-8069-c0f484c47741 2024-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE Aphena Pharma Solutions - Tennessee, LLC 53a2db10-4af8-4032-b598-b7c7a0969801 2021-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE HYDROCHLORIDE Exelan Pharmaceuticals, Inc. 2b94ecf5-d870-4132-b455-d5ee5c9dce56 2020-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 ndc (product): 76282-256 Raloxifene Hydrochloride RALOXIFENE Cipla USA Inc. 8fef5bfd-a786-4442-b09b-f3b81812cdac 2020-09-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842
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 76282-256-01 76282025601 100 TABLET, FILM COATED in 1 BOTTLE (76282-256-01) 2014-11-12 0000-00-00 No No Current 76282-256-05 76282025605 500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05) 2014-11-12 0000-00-00 No No Current 76282-256-10 76282025610 1000 TABLET, FILM COATED in 1 BOTTLE (76282-256-10) 2015-04-15 0000-00-00 No No Current 76282-256-30 76282025630 30 TABLET, FILM COATED in 1 BOTTLE (76282-256-30) 2014-11-12 0000-00-00 No No Current 76282-256-90 76282025690 90 TABLET, FILM COATED in 1 BOTTLE (76282-256-90) 2015-04-15 0000-00-00 No No Current