Home NDC 67877-882 Rivaroxaban
Product NDC 67877-882
11-digit product format 678770882
Labeler code 67877
Product ID 67877-882_d111f8d6-a073-4a43-bf16-bc1bacba9898
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rivaroxaban
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA218502
Marketing category ANDA
Marketing start 2025-07-07
Substance RIVAROXABAN
Active strength 155 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218502-001 RIVAROXABAN RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218502-001 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 2026-08-18 06:07:40 2026-07 A218502-001 RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218502-001 RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218502-001 RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218502-001 RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-06-26 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218502-001 RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-06-26 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 155 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 2588062 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 67877-882-71 Rivaroxaban 1 in 1 BOTTLE GRANULE, FOR SUSPENSION 1 5 67877-882-71 Rivaroxaban 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 5
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 · 1 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 67877-882-71 67877088271 1 BOTTLE in 1 CARTON (67877-882-71) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE 1 bottle 2025-07-07 No No Current