Home NDC 51672-4228 Rivaroxaban
Product NDC 51672-4228
11-digit product format 516724228
Labeler code 51672
Product ID 51672-4228_44213d0b-ca52-c6ac-e063-6394a90afd03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rivaroxaban
Dosage form TABLET, COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA208557
Marketing category ANDA
Marketing start 2025-10-15
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 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208557-001 RIVAROXABAN RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-03-03 A208557-002 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2025-10-07 A208557-003 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2025-10-07 A208557-004 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2025-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 A208557-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-03-03 a50c72e98297…2026-08-01 22:54:32 2026-06 A208557-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A208557-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A208557-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-10-07 a50c72e98297…
Observed Orange Book normalized TE history# 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 51672-4228-4 Rivaroxaban 60 in 1 BOTTLE TABLET, COATED 60 15 51672-4228-9 Rivaroxaban 180 in 1 BOTTLE TABLET, COATED 180 15
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51672-4228-4 51672422804 60 TABLET, COATED in 1 BOTTLE (51672-4228-4) 2025-10-15 No No Current 51672-4228-9 51672422809 180 TABLET, COATED in 1 BOTTLE (51672-4228-9) 2025-10-15 No No Current