FDA.reportPublic FDA data

NDC 68083-603-01 - Procainamide Hydrochloride

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
68083-603
Requested NDC
68083-603-01
Package NDCs from labels
68083-603-01, 68083-603-25
Manufacturer
Gland Pharma Limited
Effective date
2024-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Procainamide Hydrochloride - Gland Pharma LimitedGland Pharma Limited2024-07-23Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-603-01Procainamide Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION103
68083-603-01Procainamide Hydrochloride1 in 1 CARTONINJECTION, SOLUTION13
68083-603-25Procainamide Hydrochloride25 in 1 CASEINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-603PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]3Current NDC, 3 package rows20240730_ffde440f-7ad7-434c-bcd2-9bd8ff16d204.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 11 of 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: A2I8C7HI9T
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEInternational Medication Systems, Limitedd7cb1594-61cf-41c4-9007-1ee28aa69c502016-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SI4064O0LX
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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