NDC 42227-081

Cinryze

Human C1-esterase Inhibitor

Cinryze is a Intravenous Injection, Powder, Lyophilized, For Solution in the Plasma Derivative category. It is labeled and distributed by Viropharma Biologics Llc. The primary component is Human C1-esterase Inhibitor.

• Product ID: 42227-081_0fb47377-d040-43b5-8502-f788c67c06aa
• NDC: 42227-081
• Product Type: Plasma Derivative
• Proprietary Name: Cinryze
• Generic Name: Human C1-esterase Inhibitor
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-12-01
• Marketing Category: BLA / BLA
• Application Number: BLA125267
• Labeler Name: ViroPharma Biologics LLC
• Substance Name: HUMAN C1-ESTERASE INHIBITOR
• Active Ingredient Strength: 500 [iU]/5mL
• Pharm Classes: Decreased Vascular Permeability [PE], Human C1 Esterase Inhibitor [EPC], Kallikrein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 42227-081-05

1 VIAL, SINGLE-USE in 1 CARTON (42227-081-05) > 5 mL in 1 VIAL, SINGLE-USE (42227-081-01)

• Marketing Start Date: 2008-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42227-081-01 [42227008101]

Cinryze INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125267
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2017-01-19

NDC 42227-081-05 [42227008105]

Cinryze INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125267
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2008-12-01

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN C1-ESTERASE INHIBITOR	500 [iU]/5mL

Pharmacological Class

• Human C1 Esterase Inhibitor [EPC]
• Decreased Vascular Permeability [PE]
• Kallikrein Inhibitors [MoA]

NDC Crossover Matching brand name "Cinryze" or generic name "Human C1-esterase Inhibitor"

NDC	Brand Name	Generic Name
42227-081	Cinryze	HUMAN C1-ESTERASE INHIBITOR
42227-083	Cinryze	HUMAN C1-ESTERASE INHIBITOR
63833-825	Berinert	HUMAN C1-ESTERASE INHIBITOR
63833-828	HAEGARDA	HUMAN C1-ESTERASE INHIBITOR
63833-829	HAEGARDA	HUMAN C1-ESTERASE INHIBITOR