NDC 42976-125

ATryn

Antithrombin Recombinant

ATryn is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Revo Bioloigics, Inc.. The primary component is Antithrombin Alfa.

• Product ID: 42976-125_2c5e8a5c-7985-4cb8-9dbc-3bf646f9fe46
• NDC: 42976-125
• Product Type: Human Prescription Drug
• Proprietary Name: ATryn
• Generic Name: Antithrombin Recombinant
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-05-06
• Marketing Category: BLA / BLA
• Application Number: BLA125284
• Labeler Name: rEVO Bioloigics, Inc.
• Substance Name: ANTITHROMBIN ALFA
• Active Ingredient Strength: 525 [iU]/mL
• Pharm Classes: Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA],Recombinant Antithrombin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42976-125-01

1 VIAL in 1 CARTON (42976-125-01) > 3 mL in 1 VIAL

• Marketing Start Date: 2014-06-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42976-125-01 [42976012501]

ATryn INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125284
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-05-06
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ANTITHROMBIN ALFA	525 [iU]/mL

OpenFDA Data

• SPL SET ID: ecc5f10c-e89e-4757-a56a-9cfa6fd383f7
• Manufacturer:
  • rEVO Bioloigics, Inc.
• UNII:
  • AWV6I5L6H2
• RxNorm Concept Unique ID - RxCUI:
  • 1661563
  • 1661566

Pharmacological Class

• Decreased Coagulation Factor Activity [PE]
• Thrombin Inhibitors [MoA]
• Factor Xa Inhibitors [MoA]
• Recombinant Antithrombin [EPC]

NDC Crossover Matching brand name "ATryn" or generic name "Antithrombin Recombinant"

NDC	Brand Name	Generic Name
42976-121	ATryn	Antithrombin Recombinant
42976-125	ATryn	Antithrombin Recombinant