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 86 of 92 · 1,837 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BHI Constipation	DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED	MediNatura Inc	0365b75b-fee4-4c1d-89ab-c692bdd73f75	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	ccf5b124-083d-4465-a666-c1bc6e84d630	2022-04-29	Warnings, Adverse reactions	Exact identifier rxcui: 309594 unii: P6YC3EG204
cyanocobalamin	CYANOCOBALAMIN	Zydus Pharmaceuticals USA Inc.	e6712877-ace0-441c-99a9-adf567c0b9a2	2022-04-25	Warnings, Adverse reactions	Exact identifier rxcui: 309594 unii: P6YC3EG204
cyanocobalamin	CYANOCOBALAMIN	Zydus Lifesciences Limited	ef300a08-8212-40a9-847a-1b62348896dd	2022-04-19		Exact identifier rxcui: 309594 unii: P6YC3EG204
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Shandong Haiyan Medical Manufacture Co., Ltd.	1a117840-22d0-4a88-b1a6-e43162a444ab	2022-03-19	Warnings	Exact identifier rxcui: 797544 unii: ND2M416302
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Wild Horse 777 Moisturizing Nasal	SODIUM CHLORIDE	Wild Horse 777, Inc.	b0b4dadd-11fa-3dbb-e053-2995a90a2097	2022-03-14	Warnings	Exact identifier unii: 451W47IQ8X
Cyanocobalamin	CYANOCOBALAMIN	AuroMedics Pharma LLC	db84d0ea-5c15-47f5-bbe2-8d455e75695e	2022-03-10	Warnings, Adverse reactions	Exact identifier rxcui: 309594 unii: P6YC3EG204
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	cc14fafd-3dcd-4fc8-bdbd-6f355c375768	2022-02-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	8b44bfd3-70a4-4b47-bc7b-590f63b8cc75	2022-02-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Walgreens	SODIUM CHLORIDE	WALGREEN COMPANY	d6b9d4fc-b758-be32-e053-2995a90a2523	2022-01-29	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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