Home NDC 62332-240 RIVAROXABAN
Product NDC 62332-240
11-digit product format 623320240
Labeler code 62332
Product ID 62332-240_43438909-74d8-4b11-b947-00d06de77c88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RIVAROXABAN
Dosage form KIT
Labeler Alembic Pharmaceuticals Inc.
Application ANDA210301
Marketing category ANDA
Marketing start 2025-05-14
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 A210301-001 RIVAROXABAN RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-05-14 A210301-002 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 A210301-003 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 A210301-004 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14
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 A210301-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A210301-002 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A210301-003 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A210301-004 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base RIVAROXABAN
Listing expiration 2027-12-31 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1114198 Internal RxNorm lookup 1232082 Internal RxNorm lookup 1232086 Internal RxNorm lookup 1549682 Internal RxNorm lookup 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 62332-240-51 RIVAROXABAN 1 in 1 CARTON KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-240 RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS INC.] 5 Current NDC, 1 package rows 20250519_e62f23c6-89f2-4179-95dc-5732401b3f93.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62332-240-51 62332024051 1 KIT in 1 CARTON (62332-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2025-05-14 No No Current