Home NDC 0093-7290 Raloxifene Hydrochloride
Product NDC 0093-7290
11-digit product format 000937290
Labeler code 0093
Product ID 0093-7290_3641edbc-4bae-45d0-8afb-8db02f401f66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
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 0093-7290-01 Raloxifene Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 11 0093-7290-56 Raloxifene Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 11
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 [TEVA PHARMACEUTICALS USA INC] 3 RALOXIFENE ACTIVE MOIETY YX9162EO3I RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 3 RALOXIFENE HYDROCHLORIDE ACTIVE INGREDIENT 4F86W47BR6 RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 RALOXIFENE ACTIVE MOIETY YX9162EO3I RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-7290 RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20221019_e6be5b1d-757d-4bab-ad6a-c421960a104d.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 0093-7290-01 00093729001 100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01) 2014-03-28 0000-00-00 No No Current 0093-7290-56 00093729056 30 TABLET, FILM COATED in 1 BOTTLE (0093-7290-56) 2014-03-28 0000-00-00 No No Current