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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A078193-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-03-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A078193-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
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