NDC 86134-001-01 - GalSafe

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: 86134-001
Requested NDC: 86134-001-01
Package NDCs from labels: 86134-001-01
Manufacturer: Revivicor Inc.
Effective date: 2024-12-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
pPL657 rDNA construct in the GGTA1 gene in domestic pigs	Revivicor Inc.	2024-12-19	INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
86134-001-01	GalSafe	1 [arb'U] in 1 NOT APPLICABLE	NOT APPLICABLE	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
86134-001	GALSAFE (PPL657 RDNA CONSTRUCT IN DOMESTIC PIGS) NOT APPLICABLE [REVIVICOR INC.]	7	1 package rows	20241222_b47d3012-7b53-4ce8-aa05-1cb8bb583b8f.zip

Reported adverse events (FAERS/openFDA)#

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