NDC 69853-0101

ANDEXXA

Andexanet Alfa

ANDEXXA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Portola Pharmaceuticals. The primary component is Andexanet Alfa.

• Product ID: 69853-0101_4c6d5348-00ab-423c-86eb-dce887ad8ed3
• NDC: 69853-0101
• Product Type: Human Prescription Drug
• Proprietary Name: ANDEXXA
• Generic Name: Andexanet Alfa
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-05-14
• Marketing End Date: 2020-10-31
• Marketing Category: BLA / BLA
• Application Number: BLA125586
• Labeler Name: Portola Pharmaceuticals
• Substance Name: ANDEXANET ALFA
• Active Ingredient Strength: 100 mg/10mL
• NDC Exclude Flag: N

Packaging

NDC 69853-0101-1

4 VIAL, SINGLE-USE in 1 CARTON (69853-0101-1) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2018-05-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69853-0101-1 [69853010101]

ANDEXXA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-14
• Marketing End Date: 2020-10-31

Drug Details

Active Ingredients

Ingredient	Strength
ANDEXANET ALFA	100 mg/10mL

OpenFDA Data

• SPL SET ID: ae7f0c50-ff2d-49e5-8e10-4efa861556e6
• Manufacturer:
  • Portola Pharmaceuticals
• UNII:
  • BI009E452R
• RxNorm Concept Unique ID - RxCUI:
  • 2108130
  • 2045129
  • 2108128
  • 2045134

NDC Crossover Matching brand name "ANDEXXA" or generic name "Andexanet Alfa"

NDC	Brand Name	Generic Name
0310-3200	ANDEXXA	andexanet alfa
69853-0101	ANDEXXA	andexanet alfa
69853-0102	ANDEXXA	andexanet alfa