NDC 83278-001 - ArtemiC Rescue

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
83278-001
Package NDCs from labels
83278-001-05
Manufacturer
AMC Pharma LLC | Kinezika d.o.o.
Effective date
2024-07-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oral Spray - AMC Pharma LLC | Kinezika d.o.o.AMC Pharma LLC | Kinezika d.o.o.2024-07-05HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83278-001-052025-07-29C16284748780-11030e365-2ce2-111a-e063-dadaa90a10e2f4f29808-059e-50b4-e053-2a95a90a3006
83278-001-052024-01-30C16284748780-11030e365-2ce2-111a-e063-dadaa90a10e2f4f29808-059e-50b4-e053-2a95a90a3006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83278-001-05ArtemiC Rescue5 g in 1 BOTTLE, SPRAYSPRAY, SUSPENSION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83278-001ARTEMIC RESCUE (ORAL SPRAY) SPRAY, SUSPENSION [AMC PHARMA LLC]31 package rows20240706_f4f29808-059e-50b4-e053-2a95a90a3006.zip