NDC 13533-705

Prolastin-C Liquid

Alpha1-proteinase Inhibitor (human)

Prolastin-C Liquid is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is .alpha.1-proteinase Inhibitor Human.

• Product ID: 13533-705_243e4de6-d205-4438-a13d-f6ace0797407
• NDC: 13533-705
• Product Type: Plasma Derivative
• Proprietary Name: Prolastin-C Liquid
• Generic Name: Alpha1-proteinase Inhibitor (human)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1987-12-02
• Marketing Category: BLA / BLA
• Application Number: BLA103174
• Labeler Name: GRIFOLS USA, LLC
• Substance Name: .ALPHA.1-PROTEINASE INHIBITOR HUMAN
• Active Ingredient Strength: 1000 mg/20mL
• Pharm Classes: Human alpha-1 Proteinase Inhibitor [EPC],Trypsin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 13533-705-01

1 VIAL in 1 CARTON (13533-705-01) > 20 mL in 1 VIAL (13533-705-11)

• Marketing Start Date: 1987-12-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13533-705-11 [13533070511]

Prolastin-C Liquid INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103174
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 1987-12-02

NDC 13533-705-01 [13533070501]

Prolastin-C Liquid INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103174
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 1987-12-02

Drug Details

Active Ingredients

Ingredient	Strength
.ALPHA.1-PROTEINASE INHIBITOR HUMAN	1000 mg/20mL

Pharmacological Class

• Human alpha-1 Proteinase Inhibitor [EPC]
• Trypsin Inhibitors [MoA]