apixaban

Generic: apixaban

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name apixaban
Generic Name apixaban
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

apixaban 2.5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-337
Product ID 33342-337_396912c0-9f68-47ed-ba3f-8d9ace755a48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210067
Listing Expiration 2026-12-31
Marketing Start 2025-02-27

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 33342337
Hyphenated Format 33342-337

Supplemental Identifiers

RxCUI
1364435 1364445
UPC
0333342337153 0333342337092 0333342338150
UNII
3Z9Y7UWC1J
NUI
N0000175637 N0000175635

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 apixaban (source: ndc)
Generic Name apixaban (source: ndc)
Application Number ANDA210067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (33342-337-09)
  • 10 BLISTER PACK in 1 CARTON (33342-337-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-337-15)
source: ndc

Packages (3)

33342-337-09 60 TABLET, FILM COATED in 1 BOTTLE (33342-337-09) 33342-337-12 10 BLISTER PACK in 1 CARTON (33342-337-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-337-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-337-15)

Ingredients (1)

apixaban (2.5 mg/1)

Linked Drug Pages (1)

Apixaban ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "396912c0-9f68-47ed-ba3f-8d9ace755a48", "openfda": {"nui": ["N0000175637", "N0000175635"], "upc": ["0333342337153", "0333342337092", "0333342338150"], "unii": ["3Z9Y7UWC1J"], "rxcui": ["1364435", "1364445"], "spl_set_id": ["396912c0-9f68-47ed-ba3f-8d9ace755a48"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (33342-337-09)", "package_ndc": "33342-337-09", "marketing_start_date": "20250227"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-337-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-337-12", "marketing_start_date": "20250227"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-337-15)", "package_ndc": "33342-337-15", "marketing_start_date": "20250227"}], "brand_name": "Apixaban", "product_id": "33342-337_396912c0-9f68-47ed-ba3f-8d9ace755a48", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "33342-337", "generic_name": "Apixaban", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Apixaban", "active_ingredients": [{"name": "APIXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA210067", "marketing_category": "ANDA", "marketing_start_date": "20250227", "listing_expiration_date": "20261231"}