NDC 63833-835 - Berinert

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: 63833-835
Package NDCs from labels: 63833-835-01
Manufacturer: CSL Behring GmbH
Effective date: 2021-09-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Berinert - CSL Behring GmbH	CSL Behring GmbH	2021-09-21	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63833-835-01	Berinert	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10 mL	500 [iU] in 10mL	33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63833-835	BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]	33	Unmatched	20210928_8ea0c7fe-da9d-4218-a080-0509e09bedc6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN C1-ESTERASE INHIBITOR	ACTIVE INGREDIENT	6KIC4BB60G	BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]	20
HUMAN C1-ESTERASE INHIBITOR	ACTIVE MOIETY	6KIC4BB60G	BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]	20
Glycine	INACTIVE INGREDIENT	TE7660XO1C	BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]	20
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]	20
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]	20

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 54 of 54 · 1,061 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
249c9738-7dfa-4f18-8330-be14437da235			8ea0c7fe-da9d-4218-a080-0509e09bedc6	2009-11-10	Warnings, Adverse reactions	Exact identifier spl set id: 8ea0c7fe-da9d-4218-a080-0509e09bedc6

Reported adverse events (FAERS/openFDA)#

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