Home NDC 76282-774 Rivaroxaban
Product NDC 76282-774
11-digit product format 762820774
Labeler code 76282
Product ID 76282-774_fcd1f593-213c-490f-b0d1-75b2d7817582
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rivaroxaban
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Exelan pharmaceuticals,Inc
Application ANDA218117
Marketing category ANDA
Marketing start 2025-08-04
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 A218117-001 RIVAROXABAN RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-07-31 A218117-002 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2025-07-31 A218117-003 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2025-07-31 A218117-004 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2025-07-31
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 A218117-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218117-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218117-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218117-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218117-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218117-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218117-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218117-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218117-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218117-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218117-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218117-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218117-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218117-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218117-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218117-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-07-31 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218117-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-07-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218117-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-07-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218117-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-07-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218117-004 RIVAROXABAN 20MG TABLET / ORAL AB 2025-07-31 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 76282-774-18 Rivaroxaban 180 in 1 BOTTLE TABLET, FILM COATED 180 1 76282-774-60 Rivaroxaban 60 in 1 BOTTLE TABLET, FILM COATED 60 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 Marketing start Sample Exclude flag Status 76282-774-18 76282077418 180 TABLET, FILM COATED in 1 BOTTLE (76282-774-18) 2025-08-04 No No Current 76282-774-60 76282077460 60 TABLET, FILM COATED in 1 BOTTLE (76282-774-60) 2025-08-04 No No Current