Home NDC 55488-0541 rivaroxaban
Product NDC 55488-0541
11-digit product format 554880541
Labeler code 55488
Product ID 55488-0541_8b1205ed-1f1c-4e13-8076-aefada9213ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rivaroxaban
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Changzhou Pharmaceutical Factory
Application ANDA216995
Marketing category ANDA
Marketing start 2026-02-01
Substance RIVAROXABAN
Active strength 15 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216995-001 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 A216995-002 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 A216995-003 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A216995-001 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A216995-002 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A216995-003 RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14 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 15 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1114198 Internal RxNorm lookup 1232082 Internal RxNorm lookup 1232086 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 55488-0541-1 rivaroxaban 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55488-0541-1 55488054101 30 TABLET, FILM COATED in 1 BOTTLE (55488-0541-1) 2026-02-01 No No Current