apixaban

Generic: apixaban

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name apixaban
Generic Name apixaban
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

apixaban 5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1722
Product ID 0115-1722_ac3db938-22a3-42a0-ac3a-8628d9e0a7cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209810
Listing Expiration 2026-12-31
Marketing Start 2018-08-31

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 01151722
Hyphenated Format 0115-1722

Supplemental Identifiers

RxCUI
1364435 1364445
UPC
0301151721135 0301151722132
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 ANDA209810 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13)
source: ndc

Packages (3)

0115-1722-01 10 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15) 0115-1722-03 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03) 0115-1722-13 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13)

Ingredients (1)

apixaban (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": "ac3db938-22a3-42a0-ac3a-8628d9e0a7cf", "openfda": {"nui": ["N0000175637", "N0000175635"], "upc": ["0301151721135", "0301151722132"], "unii": ["3Z9Y7UWC1J"], "rxcui": ["1364435", "1364445"], "spl_set_id": ["19a60552-374d-4b8b-a8ce-ceae252ea5ba"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0115-1722-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15)", "package_ndc": "0115-1722-01", "marketing_start_date": "20180831"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03)", "package_ndc": "0115-1722-03", "marketing_start_date": "20180831"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13)", "package_ndc": "0115-1722-13", "marketing_start_date": "20180831"}], "brand_name": "Apixaban", "product_id": "0115-1722_ac3db938-22a3-42a0-ac3a-8628d9e0a7cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "0115-1722", "generic_name": "Apixaban", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Apixaban", "active_ingredients": [{"name": "APIXABAN", "strength": "5 mg/1"}], "application_number": "ANDA209810", "marketing_category": "ANDA", "marketing_start_date": "20180831", "listing_expiration_date": "20261231"}