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 ID13533-705_243e4de6-d205-4438-a13d-f6ace0797407
NDC13533-705
Product TypePlasma Derivative
Proprietary NameProlastin-C Liquid
Generic NameAlpha1-proteinase Inhibitor (human)
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1987-12-02
Marketing CategoryBLA / BLA
Application NumberBLA103174
Labeler NameGRIFOLS USA, LLC
Substance Name.ALPHA.1-PROTEINASE INHIBITOR HUMAN
Active Ingredient Strength1000 mg/20mL
Pharm ClassesHuman alpha-1 Proteinase Inhibitor [EPC],Trypsin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 13533-705-01

1 VIAL in 1 CARTON (13533-705-01) > 20 mL in 1 VIAL (13533-705-11)
Marketing Start Date1987-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13533-705-11 [13533070511]

Prolastin-C Liquid INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103174
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date1987-12-02

NDC 13533-705-01 [13533070501]

Prolastin-C Liquid INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103174
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date1987-12-02

Drug Details

Active Ingredients

IngredientStrength
.ALPHA.1-PROTEINASE INHIBITOR HUMAN1000 mg/20mL

Pharmacological Class

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

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