apixaban

Generic: apixaban

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

apixaban 2.5 mg/1

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-149
Product ID 14445-149_6a6e421b-6ed3-403c-b07d-09dbbd6a487c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209898
Listing Expiration 2026-12-31
Marketing Start 2020-09-16

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 14445149
Hyphenated Format 14445-149

Supplemental Identifiers

RxCUI
1364435 1364445
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 ANDA209898 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05)
  • 1 TABLET, FILM COATED in 1 CARTON (14445-149-10)
  • 1 TABLET, FILM COATED in 1 CARTON (14445-149-14)
  • 180 TABLET, FILM COATED in 1 BOTTLE (14445-149-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (14445-149-60)
source: ndc

Packages (5)

14445-149-05 500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05) 14445-149-10 1 TABLET, FILM COATED in 1 CARTON (14445-149-10) 14445-149-14 1 TABLET, FILM COATED in 1 CARTON (14445-149-14) 14445-149-18 180 TABLET, FILM COATED in 1 BOTTLE (14445-149-18) 14445-149-60 60 TABLET, FILM COATED in 1 BOTTLE (14445-149-60)

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": "6a6e421b-6ed3-403c-b07d-09dbbd6a487c", "openfda": {"nui": ["N0000175637", "N0000175635"], "unii": ["3Z9Y7UWC1J"], "rxcui": ["1364435", "1364445"], "spl_set_id": ["095a08ac-cf0e-497e-a682-ddef38d6b29c"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05)", "package_ndc": "14445-149-05", "marketing_start_date": "20200916"}, {"sample": false, "description": "1 TABLET, FILM COATED in 1 CARTON (14445-149-10)", "package_ndc": "14445-149-10", "marketing_start_date": "20200916"}, {"sample": false, "description": "1 TABLET, FILM COATED in 1 CARTON (14445-149-14)", "package_ndc": "14445-149-14", "marketing_start_date": "20200916"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (14445-149-18)", "package_ndc": "14445-149-18", "marketing_start_date": "20200916"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (14445-149-60)", "package_ndc": "14445-149-60", "marketing_start_date": "20200916"}], "brand_name": "apixaban", "product_id": "14445-149_6a6e421b-6ed3-403c-b07d-09dbbd6a487c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "14445-149", "generic_name": "apixaban", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "apixaban", "active_ingredients": [{"name": "APIXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA209898", "marketing_category": "ANDA", "marketing_start_date": "20200916", "listing_expiration_date": "20261231"}