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 1 of 98 · 1,944 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: ND2M416302
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
rxcui: 797544
unii: ND2M416302
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
MeijerISOPROPYL ALCOHOLMeijer Distribution Incca008d84-cf51-3703-e053-2a95a90a9bf12026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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