NDC 0006-5068 - WINREVAIR

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: 0006-5068
Package NDCs from labels: 0006-5068-99
Manufacturer: Merck Sharp & Dohme LLC
Effective date: 2026-09-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
WINREVAIR - Merck Sharp & Dohme LLC	Merck Sharp & Dohme LLC	2026-09-21	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-5068-99	WINREVAIR	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	2 mL	45 mg in 1mL	8
0006-5068-99	WINREVAIR	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1 mL	45 mg in 1mL	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-5068	WINREVAIR (SOTATERCEPT-CSRK) KIT [MERCK SHARP & DOHME LLC]	4	Unmatched	20250507_21693ee2-cd23-4137-ac67-066bb3a4a9b7.zip

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 16 of 16 · 301 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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