Home NDC 60687-266 Raloxifene Hydrochloride
Product NDC 60687-266
11-digit product format 606870266
Labeler code 60687
Product ID 60687-266_18588c41-973d-4ebc-e063-6294a90a5eed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA090842
Marketing category ANDA
Marketing start 2016-11-09
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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 60687-266-11 Raloxifene Hydrochloride 1 in 1 BLISTER PACK TABLET 1 8 60687-266-21 Raloxifene Hydrochloride 30 in 1 BOX, UNIT-DOSE TABLET 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-266 RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [AMERICAN HEALTH PACKAGING] 8 Current NDC, Legacy NDC, 2 package rows 20240514_f5c25553-1546-451d-8069-c0f484c47741.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 ndc (product): 60687-266 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 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 Units Marketing start Marketing end Sample Exclude flag Status 60687-266-11 60687026611 1 in 1 BLISTER PACK Historical 60687-266-21 60687026621 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-266-21) / 1 TABLET in 1 BLISTER PACK (60687-266-11) 30 blister pack 2016-11-09 0000-00-00 No No Current