FDA.reportPublic FDA data

NDC 63323-044-00 - 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
63323-044-00
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 48 of 92 · 1,837 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUBBING ALCOHOL 50 PERCENT WINTERGREENISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83f562-7ec7-72f3-e063-6294a90aba4d2025-07-01WarningsExact identifier
unii: ND2M416302
RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83e678-b79f-6dd6-e063-6294a90ad09d2025-07-01WarningsExact identifier
unii: ND2M416302
RUBBING ALCOHOL 70 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4babe369-3a35-34b5-e063-6394a90a68322025-07-01WarningsExact identifier
unii: ND2M416302
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
unii: ND2M416302
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Leuprolide AcetateLEUPROLIDE ACETATENorthStar RxLLC0cf31b40-816b-d055-e063-6294a90af5d02025-06-24Warnings, Adverse reactionsExact identifier
rxcui: 797544
Good Neighbor Pharmacy Alcohol Antiseptic Skin CleanserISOPROPYL ALCOHOLAmerisouce Bergenfc28cf11-afb9-4295-bee3-735ab10f6bbc2025-06-24WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: ND2M416302
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
WISH RUBBING ALCOHOL 99%ISOPROPYL ALCOHOLLJ Pharmaa06953d7-d685-45ac-b1c6-e66dc7a05bca2025-06-18WarningsExact identifier
unii: ND2M416302
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC1fdff866-f534-4c16-b755-b2efd1e6e8372025-06-17WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 99% WINTERGREENISOPROPYL ALCOHOLLJ Pharmade7b2253-7f36-4a27-8838-442ec635f69b2025-06-16WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70% WINTERGREENISOPROPYL ALCOHOLLJ Pharma98ebf7a7-7c13-4feb-90b5-21cc6dab99f62025-06-16WarningsExact identifier
unii: ND2M416302
HAND-I-SAN75% ISOPROPYL ALCOHOL HAND SANITIZERZECO, LLC37627a51-cf31-013c-e063-6294a90ae13a2025-06-13WarningsExact identifier
unii: ND2M416302
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.064c6841-3ed2-417f-a77c-a730785b60362025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 451W47IQ8X
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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