rivaroxaban granule

Generic: rivaroxaban granule

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rivaroxaban granule
Generic Name rivaroxaban granule
Labeler lupin pharmaceuticals, inc.
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

rivaroxaban 155 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-355
Product ID 70748-355_1f47ffee-bd05-4c0e-a399-b6961cc80b34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218195
Listing Expiration 2026-12-31
Marketing Start 2025-09-29

Pharmacologic Class

Established (EPC)
factor xa inhibitor [epc]
Mechanism of Action
factor xa inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748355
Hyphenated Format 70748-355

Supplemental Identifiers

RxCUI
2588062
UPC
0370748355015
UNII
9NDF7JZ4M3
NUI
N0000175635 N0000175637

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rivaroxaban granule (source: ndc)
Generic Name rivaroxaban granule (source: ndc)
Application Number ANDA218195 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 155 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE
source: ndc

Packages (1)

70748-355-01 1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE

Ingredients (1)

rivaroxaban (155 mg/1)

Linked Drug Pages (1)

rivaroxaban granule ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1f47ffee-bd05-4c0e-a399-b6961cc80b34", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0370748355015"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2588062"], "spl_set_id": ["b0306b06-d8cf-48de-9e93-57d77e4e98f5"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-355-01)  / 1 FOR SUSPENSION in 1 BOTTLE", "package_ndc": "70748-355-01", "marketing_start_date": "20250929"}], "brand_name": "rivaroxaban granule", "product_id": "70748-355_1f47ffee-bd05-4c0e-a399-b6961cc80b34", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "70748-355", "generic_name": "rivaroxaban granule", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "rivaroxaban granule", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "155 mg/1"}], "application_number": "ANDA218195", "marketing_category": "ANDA", "marketing_start_date": "20250929", "listing_expiration_date": "20261231"}