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
Label	Manufacturer	Effective date	Type
Cyanocobalamin - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2024-12-15	HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL
Physicians EZ Use B-12 Compliance - Asclemed USA, Inc.	Asclemed USA, Inc.	2024-10-05	HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2021-07-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-044-00	Physicians EZ Use B-12 Compliance	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1 mL	1000 ug in 1mL	6
63323-044-00	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1		4
63323-044-01	Cyanocobalamin	25 in 1 TRAY	INJECTION, SOLUTION	25		4
63323-044-41	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1		3
63323-044-44	Cyanocobalamin	25 in 1 TRAY	INJECTION, SOLUTION	25		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-044	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [ASCLEMED USA, INC.]	6	Current NDC, Legacy NDC	20241008_168f94ea-2faf-4aeb-88a5-8753ad60a1c4.zip
63323-044	CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250123_acff4ff3-4435-4995-a117-dbfcdf72334a.zip
63323-044	CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241220_8b1cdee5-3368-40e4-90bf-31a64df1f38a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-044-00	ML - Milliliter	63323-044	7c5040c2-0354-43d8-8ebb-8a27739fae52	1	2019-10-07
63323-044-01	ML - Milliliter	63323-044	2ed89db3-669d-4f3f-8ce0-e54f60e1cc8a	1	2012-07-24
63323-044-41	ML - Milliliter	63323-044	ab4fa83b-78e6-4dce-82c3-0de939a7301a	1	2019-03-12
63323-044-44	ML - Milliliter	63323-044	eccf56c0-c974-4c3a-adaf-0aafd7f3dceb	1	2019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cyanocobalamin	ACTIVE INGREDIENT	P6YC3EG204	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
Isopropyl Alcohol	ACTIVE INGREDIENT	ND2M416302	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
Cyanocobalamin	ACTIVE MOIETY	P6YC3EG204	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
Isopropyl Alcohol	ACTIVE MOIETY	ND2M416302	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHYSICIANS 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 88 of 92 · 1,824 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 451W47IQ8X
Cyanocobalamin	CYANOCOBALAMIN	Asclemed USA, Inc.	66e3441f-79fa-4a1b-be22-2bc683cd7abc	2021-07-08	Warnings, Adverse reactions	Exact identifier application number: ANDA080557 ndc (package): 76420-111-25 ndc (product): 76420-111 rxcui: 309594 spl id: c6976242-83a1-4644-e053-2995a90a0904 spl set id: 66e3441f-79fa-4a1b-be22-2bc683cd7abc unii: P6YC3EG204
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ed8fd0c1-ac42-4267-877e-ceadf3831c90	2021-04-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dr. Talbots Vital 12	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC	Talbot's Pharmaceuticals Family Products, LLC	c10bb804-8169-63da-e053-2a95a90a8306	2021-04-28	Warnings	Exact identifier unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC	c0963200-67dd-6349-e053-2a95a90adde1	2021-04-22	Warnings	Exact identifier unii: 451W47IQ8X
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	c3f8e83c-4fb9-91da-e053-2a95a90abd63	2021-04-12	Adverse reactions	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live Better	SODIUM CHLORIDE	CVS Pharmacy	ccc3ab8c-b22f-420d-869b-f2a65b8c7180	2021-03-13	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	aeaed9cb-b629-4019-88d2-a916179427de	2021-02-19	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GUNA KIDNEY PLUS	CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -	Guna spa	b8dacd94-8da1-4a8d-e053-2995a90acb67	2021-02-04	Warnings	Exact identifier unii: 451W47IQ8X
Natrum Muriaticum	NATRUM MURIATICUM	True Botanica, LLC	b30b2880-28a1-47bd-83e7-da885a7c6f77	2021-01-24	Warnings	Exact identifier unii: 451W47IQ8X
Met-Tox	ARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODES	wHITE mANUFACTURING INC DBA MICRO-WEST	e65db4c2-0bc7-4c50-8f18-b36ee004c4f5	2021-01-21	Warnings	Exact identifier unii: 451W47IQ8X
HPZ	ECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCC	White Manufacturing Inc. DBA Micro-West	dfbb5a35-8dfe-48f4-9177-6cb52fb44090	2021-01-21	Warnings	Exact identifier unii: 451W47IQ8X
Metal	ALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIA	NET Remedies	f7682a4e-c767-4429-98aa-e8c5ef6560a6	2021-01-19	Warnings	Exact identifier unii: 451W47IQ8X
3% Sodium Chloride	3% SODIUM CHLORIDE	Becton Dickinson and Company	a8058593-48af-457a-b0f0-166935c7d10c	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Asclemed USA, Inc.	a411c118-ef0e-4c42-9924-4a06ec690e94	2021-01-14	Adverse reactions	Exact identifier unii: 451W47IQ8X
Intestia	ECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUM	Newton Laboratories, Inc.	9a132c99-7278-f667-e053-2a95a90a3d2b	2020-12-04	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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