NDC 13533-702 - PROLASTIN-C

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 13533-702
Package NDCs from labels: 13533-702-11
Manufacturer: GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
Effective date: 2022-02-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PROLASTIN-C - GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2022-02-25	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13533-702-11	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	1000 mg in 20mL	25
13533-702-11	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	1000 mg in 20mL	25
13533-702-11	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	1000 mg in 20mL	25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13533-702	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC]	25	Unmatched	20220308_91edab72-c889-470e-8315-1798b5548dca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Alpha-1-proteinase Inhibitor Human	ACTIVE INGREDIENT	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Alpha-1-proteinase Inhibitor Human	ACTIVE MOIETY	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Phosphate	INACTIVE INGREDIENT	SE337SVY37	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 52 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
16e28bfa-1146-21c9-7ab3-a3ec08cdf2b4			91edab72-c889-470e-8315-1798b5548dca	2009-10-31	Warnings, Adverse reactions	Exact identifier spl set id: 91edab72-c889-470e-8315-1798b5548dca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.