Home NDC 71921-405 rivaroxaban
Product NDC 71921-405
11-digit product format 719210405
Labeler code 71921
Product ID 71921-405_f0ef9361-f06d-4028-97af-183b545f4aea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rivaroxaban
Dosage form TABLET
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA218445
Marketing category ANDA
Marketing start 2025-08-20
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 42 .
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 A218445-001 RIVAROXABAN RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-08-11 A218445-002 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2025-08-11 A218445-003 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2025-08-11 A218445-004 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2025-08-11
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 2026-08-18 06:07:40 2026-07 A218445-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218445-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218445-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218445-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218445-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218445-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218445-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218445-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218445-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218445-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218445-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218445-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-08-11 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218445-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-08-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218445-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-08-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218445-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-08-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218445-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-08-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base rivaroxaban
Listing expiration 2026-12-31 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 71921-405-06 rivaroxaban 60 in 1 BOTTLE TABLET 60 1 71921-405-21 rivaroxaban 180 in 1 BOTTLE TABLET 180 1
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 Units Marketing start Sample Exclude flag Status 71921-405-06 71921040506 60 TABLET in 1 BOTTLE (71921-405-06) 60 tablet 2025-08-20 No No Current 71921-405-21 71921040521 180 TABLET in 1 BOTTLE (71921-405-21) 180 tablet 2025-08-20 No No Current