NDC 58160-855-01 - Arepanrix

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: 58160-855
Requested NDC: 58160-855-01
Package NDCs from labels: 58160-855-01, 58160-855-19
Manufacturer: GlaxoSmithKline Biologicals SA
Effective date: 2026-04-28
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Arepanrix - GlaxoSmithKline Biologicals SA	GlaxoSmithKline Biologicals SA	2026-04-28	VACCINE LABEL
AS03 - GlaxoSmithKline Biologicals SA	GlaxoSmithKline Biologicals SA	2025-12-31	VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58160-855-19	2024-02-10	C162847	48780-1	1030e365-6622-111a-e063-dadaa90a10e2	f136b41b-56f3-43a9-9d6a-61b2afca5b4a
58160-855-19	2024-01-30	C162847	48780-1	1030e365-6622-111a-e063-dadaa90a10e2	f136b41b-56f3-43a9-9d6a-61b2afca5b4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58160-855-01	AS03	2.5 mL in 1 VIAL	INJECTION, SOLUTION	2.5		3
58160-855-19	AS03	10 in 1 CARTON	INJECTION, SOLUTION	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58160-855	AS03 INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]	2	Current NDC, Legacy NDC, 2 package rows	20240210_f136b41b-56f3-43a9-9d6a-61b2afca5b4a.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 76 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10 unii: 4J9FJ0HL51 unii: 70WT22SF4B
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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