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 12 of 96 · 1,920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
unii: ND2M416302
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Non-proprietary nameCYANOCOBALAMINXseer Pharmaceuticals3bb870d8-128d-75ea-e063-6394a90a707b2026-05-13Exact identifier
unii: P6YC3EG204
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Norixa MiniNORIXA MINIFlorrax Pharmaceutical0aba2b6f-50b2-48c1-992b-d481b5394d532026-05-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
caring mill Lavender Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.fcbb6b34-6f0e-4b82-8b3f-1d702d88079a2026-05-11WarningsExact identifier
rxcui: 797544
unii: ND2M416302
LEUPROLIDE ACETATELEUPROLIDE ACETATEEugia US LLC49a1d0c1-304c-46f2-a780-bd940ae1ced02026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 797544
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Lightning X Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.5136065e-8dc9-0dae-e063-6294a90a3f9d2026-05-07WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ABRILADAADALIMUMAB-AFZBPfizer Laboratories Div Pfizer Inc5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
caring mill Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.80997bb6-b878-45d4-a6e9-4ae37442d67e2026-05-06WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Redicare Alcohol Prep PadsMEDIUM ALCOHOL PREP PADSRedicare LLC3cb7fba1-1d2d-f4da-e063-6394a90a4b212026-05-01WarningsExact identifier
rxcui: 797544
unii: ND2M416302
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Inc11d89d11-103e-4ef6-a996-65cff67f9b322026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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