FDA.reportPublic FDA data

NDC 63323-044-41 - Cyanocobalamin

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
63323-044
Requested NDC
63323-044-41
Package NDCs from labels
63323-044-00, 63323-044-01, 63323-044-41, 63323-044-44
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-12-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyanocobalamin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-12-15HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-12-12HUMAN PRESCRIPTION DRUG LABEL
Physicians EZ Use B-12 Compliance - Asclemed USA, Inc.Asclemed USA, Inc.2024-10-05HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2021-07-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-044-00Physicians EZ Use B-12 Compliance1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1 mL1000 ug in 1mL6
63323-044-00Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION14
63323-044-01Cyanocobalamin25 in 1 TRAYINJECTION, SOLUTION254
63323-044-41Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION13
63323-044-44Cyanocobalamin25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-044PHYSICIANS EZ USE B-12 COMPLIANCE KIT [ASCLEMED USA, INC.]6Current NDC, Legacy NDC20241008_168f94ea-2faf-4aeb-88a5-8753ad60a1c4.zip
63323-044CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20250123_acff4ff3-4435-4995-a117-dbfcdf72334a.zip
63323-044CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241220_8b1cdee5-3368-40e4-90bf-31a64df1f38a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-044-00ML - Milliliter63323-0447c5040c2-0354-43d8-8ebb-8a27739fae5212019-10-07
63323-044-01ML - Milliliter63323-0442ed89db3-669d-4f3f-8ce0-e54f60e1cc8a12012-07-24
63323-044-41ML - Milliliter63323-044ab4fa83b-78e6-4dce-82c3-0de939a7301a12019-03-12
63323-044-44ML - Milliliter63323-044eccf56c0-c974-4c3a-adaf-0aafd7f3dceb12019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CyanocobalaminACTIVE INGREDIENTP6YC3EG204PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
CyanocobalaminACTIVE MOIETYP6YC3EG204PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
Isopropyl AlcoholACTIVE MOIETYND2M416302PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]1

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 45 of 96 · 1,920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus Alcohol Wipes70% ISOPROPYL ALCOHOLUnifirst First Aid Corporation3f507990-282a-4b26-e054-00144ff8d46c2025-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Green Guard Sterile Alcohol WipesISOPROPYL ALCOHOL 70%Unifirst First Aid Corporation570baa70-e519-328b-e054-00144ff8d46c2025-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Medi-First Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce650cb6-5398-29e7-e053-2995a90ac7972025-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Medi-First Sting ReliefBENZOCAINE 6%, ISOPROPYL ALCOHOL 60%Unifirst First Aid Corporation6e610821-b030-930b-e053-2a91aa0a66f92025-09-08WarningsExact identifier
unii: ND2M416302
Medi-First Isopropyl AlcoholISOPROPYL ALCOHOLUnifirst First Aid Corporationdbee035e-094f-f8a3-e053-2995a90a66202025-09-08WarningsExact identifier
unii: ND2M416302
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbfbf8cf-201b-2277-e053-2995a90a6e452025-09-08WarningsExact identifier
unii: ND2M416302
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
cyanocobalaminCYANOCOBALAMINSomerset Therapeutics, LLC41ac0dc1-0a71-4c69-8e25-ba838f5f16a32025-09-04Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AeroWipeSTING RELIEF PADAero Healthcare US LLC3d851c98-c9b9-f084-e063-6294a90acde22025-08-29WarningsExact identifier
unii: ND2M416302
CYANOCOBALAMINCYANOCOBALAMINSomerset Therapeutics, LLC617e44f8-df80-4764-85b9-be0fb6da8db32025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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