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
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 20 of 93 · 1,857 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Maximum Strength	URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	122ca23e-43f1-4e5c-afc2-1418b1717679	2026-02-20	Warnings	Exact identifier unii: 451W47IQ8X
Back Pain Pain Management	ARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDE	Forces of Nature	bf089347-f334-4d6d-ab58-cf7f0b16810f	2026-02-20	Warnings	Exact identifier unii: 451W47IQ8X
PDI Alcohol Prep Pad Sterile Large and Medium	ALCOHOL	Professional Disposables International Inc	8fe9cf1c-3f5f-4873-9648-6d4c79f8cf03	2026-02-18	Warnings	Exact identifier rxcui: 797544
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Target Corporation	b5455e53-2b86-48e7-a479-664f6601bab7	2026-02-18	Warnings, Adverse reactions	Exact identifier unii: ND2M416302
Travel Wipes Unscented	ISOPROPYL ALCOHOL	SINGULAR ENTERPRISES LLC	dd046146-fda7-438c-98ca-96ea1dd0ae0b	2026-02-18	Warnings	Exact identifier rxcui: 797544 unii: ND2M416302
70%	ISOPROPYL ALCOHOL	Target Corporation	4db7c9cb-021d-463a-9ff6-91ae42f0311d	2026-02-18	Warnings, Adverse reactions	Exact identifier unii: ND2M416302
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Valu Merchandisers Company	a631c976-cb9b-4099-8630-2a10c14bd3bd	2026-02-16	Warnings, Adverse reactions	Exact identifier unii: ND2M416302
70%	ISOPROPYL ALCOHOL	Valu Merchandisers Company	be57aa83-f097-4ff8-81f8-13d731eea4e6	2026-02-16	Warnings, Adverse reactions	Exact identifier unii: ND2M416302
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Valu Merchandisers Company	81b5a92a-27a9-41d2-bc88-920833be6638	2026-02-16	Warnings, Adverse reactions	Exact identifier unii: ND2M416302
RHODODIUM	ACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRON	BM Private Limited	3b3bcba2-6f9e-cd94-e063-6394a90a7701	2026-02-15	Warnings	Exact identifier unii: 451W47IQ8X
Aflora	MULTIVITAMIN	Oncora Pharma, LLC	38e463d1-f608-7cb5-e063-6294a90a4abb	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
Folixia	MULTIVITAMIN	Oncora Pharma, LLC	413945b5-116b-d8b6-e063-6394a90a55e8	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
Nutralyn	MULTIVITAMIN	Oncora Pharma, LLC	33da017b-1e8c-d41c-e063-6394a90aab8c	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
Folaten	MULTIVITAMIN	Oncora Pharma, LLC	93086235-2c33-424d-b0c3-213031988581	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
Floravita Mini	FLORAVITA MINI	Florrax Pharmaceutical	682bda57-21e0-47df-9596-78846d4d97c0	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
Isopropyl alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	26e10080-d389-4994-e054-00144ff8d46c	2026-02-11	Warnings	Exact identifier unii: ND2M416302
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	d980969d-694b-4c9e-a931-73beaceb51da	2026-02-11	Warnings	Exact identifier unii: ND2M416302
Isopropyl alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	2c85e3c0-2876-31c3-e054-00144ff88e88	2026-02-11	Warnings	Exact identifier unii: ND2M416302
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	52a8b96e-dd4f-449e-b819-6f3ec5a27fb4	2026-02-11	Warnings	Exact identifier unii: ND2M416302
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Topco Associates LLC	be4f41bd-8a75-4fb6-8d28-67f6f853e6bd	2026-02-11	Warnings, Adverse reactions	Exact identifier unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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