Home NDC 60505-6256 Rivaroxaban
Product NDC 60505-6256
11-digit product format 605056256
Labeler code 60505
Product ID 60505-6256_0e1a0098-1b42-db14-8e0f-23c8ee1e35cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rivaroxaban
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA217810
Marketing category ANDA
Marketing start 2025-05-02
Substance RIVAROXABAN
Active strength 2.5 mg/1
Pharmacologic classes Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A217810-001 RIVAROXABAN RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217810-001 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 A217810-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-05-02 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 A217810-001 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Rivaroxaban
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIVAROXABAN 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9NDF7JZ4M3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2059015 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 60505-6256-5 Rivaroxaban 500 in 1 BOTTLE TABLET, FILM COATED 500 3 60505-6256-6 Rivaroxaban 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6256 RIVAROXABAN TABLET, FILM COATED [APOTEX CORP.] 1 Current NDC, 2 package rows 20250503_e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60505-6256-5 60505625605 500 TABLET, FILM COATED in 1 BOTTLE (60505-6256-5) 2025-05-02 No No Current 60505-6256-6 60505625606 60 TABLET, FILM COATED in 1 BOTTLE (60505-6256-6) 2025-05-02 No No Current