Home NDC 0002-4184 Evista
Product NDC 0002-4184
11-digit product format 000024184
Labeler code 0002
Product ID 0002-4184_d46edd04-2907-438c-9e1f-b94b5509c0fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene hydrochloride
Dosage form TABLET
Route ORAL
Labeler Eli Lilly and Company
Application NDA020815
Marketing category NDA
Marketing start 1998-01-06
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 N020815-001 EVISTA RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB RLD, RS 1997-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020815-001 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 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 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 Evista
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1490065 Internal RxNorm lookup 1490067 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 0002-4184-30 Evista 30 in 1 BOTTLE TABLET 30 31
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-4184 EVISTA (RALOXIFENE HYDROCHLORIDE) TABLET [ELI LILLY AND COMPANY] 30 Current NDC, Legacy NDC, 1 package rows 20241206_fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Evista RALOXIFENE HYDROCHLORIDE Eli Lilly and Company fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9 2025-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020815 application number: NDA020815 ndc (product): 0002-4184
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 0002-4184-02 00002418402 100 TABLET in 1 BOTTLE (0002-4184-02) 100 tablet 2016-12-16 0000-00-00 No No Current 0002-4184-30 00002418430 30 TABLET in 1 BOTTLE (0002-4184-30) 30 tablet 2016-12-16 0000-00-00 No No Current