Home NDC 70748-355 rivaroxaban granule
Product NDC 70748-355
11-digit product format 707480355
Labeler code 70748
Product ID 70748-355_75d51b1e-1d97-40c7-854e-4736e335e048
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rivaroxaban granule
Dosage form FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA218195
Marketing category ANDA
Marketing start 2025-09-29
Substance RIVAROXABAN
Active strength 155 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218195-001 RIVAROXABAN RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218195-001 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 2026-08-01 22:54:32 2026-06 A218195-001 RIVAROXABAN 1MG/ML FOR SUSPENSION / ORAL AB 2025-09-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A218195-001 AB 1 a50c72e98297…
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 granule
Listing expiration 2027-12-31 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 70748-355-01 rivaroxaban granule 1 in 1 CARTON FOR SUSPENSION 1 7 70748-355-01 rivaroxaban granule 1 in 1 BOTTLE FOR SUSPENSION 1 7
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70748-355-01 70748035501 1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE 1 bottle 2025-09-29 No No Current