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 79 of 92 · 1,837 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
Stomach Enzyme FormulaBETAINUM MURIATICUM, MURIATICUM ACIDUM, NATRUM PHOSPHORICUM, PANCREAS SUIS, STOMACH (SUIS) SYMPHYTUM OFFICINALE, PEPSINUMNutritional Specialties, Inc.992e6f61-abc9-4146-a9da-5ada4a627aa72023-10-04WarningsExact identifier
unii: QTT17582CB
CyanocobalaminCYANOCOBALAMINAsclemed USA, Inc.071f7c95-7243-4014-b336-db8962ac0f752023-10-03Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
rxcui: 797544
unii: ND2M416302
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: 451W47IQ8X
Epiforce P-HPARSENICUM ALBUM, BORAX, GRAPHITES, NATRUM MURIATICUM, SEPIA, SULPHURBioActive Nutritional, Inc.250441d1-e261-417e-9100-700368ea38fd2023-09-11WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.a9910e09-5aea-4ee1-a35e-ae4abf8b80b42023-09-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
unii: ND2M416302
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
unii: ND2M416302
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: LKG8494WBH
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: ND2M416302
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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