NDC 83787-113 - ZELSUVMI

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: 83787-113
Package NDCs from labels: 83787-113-14
Manufacturer: LNHC, Inc.
Effective date: 2025-07-08
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ZELSUVMI - LNHC, Inc.	LNHC, Inc.	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83787-113	ZELSUVMI (BERDAZIMER) KIT [LNHC, INC.]	2	Unmatched	20250406_76b17622-bdb9-41ea-b962-c2acc0df71f7.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZELSUVMI	BERDAZIMER	LNHC, Inc.	76b17622-bdb9-41ea-b962-c2acc0df71f7	2025-07-08	Warnings, Adverse reactions	Exact identifier application number: NDA217424 ndc (package): 83787-113-14 ndc (package): 83787-103-31 ndc (product): 83787-103 rxcui: 2710443 rxcui: 2710438 spl id: 0af12ae7-bb37-4319-94d1-8074b39d4e1b spl set id: 76b17622-bdb9-41ea-b962-c2acc0df71f7

Reported adverse events (FAERS/openFDA)#

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