FDA.reportPublic FDA data

NDC 58005-426 - VITAMIN B12 3000

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
58005-426
Package NDCs from labels
58005-426-04, 58005-426-05
Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2015-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VITAMIN B12 INJECTION 3000 mcgSparhawk Laboratories, Inc.2015-04-22PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58005-426-04VITAMIN B12 3000100 mL in 1 VIALINJECTION1002
58005-426-05VITAMIN B12 3000250 mL in 1 VIALINJECTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-426VITAMIN B12 3000 (CYANOCOBALAMIN) INJECTION [SPARHAWK LABORATORIES, INC.]22 package rows20150422_ff35c1b3-e9ee-487d-9542-0a9316edf5fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204VITAMIN B12 3000 (CYANOCOBALAMIN) INJECTION [SPARHAWK LABORATORIES, INC.]2
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204VITAMIN B12 3000 (CYANOCOBALAMIN) INJECTION [SPARHAWK LABORATORIES, INC.]2

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 5 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-138GARLIC, VISCUM ALBUM FRUITING TOP, OLEA EUROPAEA FLOWER BUD, PRUNUS DULCIS FLOWER, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, POTASSIUM IODIDE, AND CHOLESTEROLDNA Labs, Inc.3f17a0a3-7eff-477a-a21f-fc3f94f0a8ec2025-01-13WarningsExact identifier
unii: P6YC3EG204
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst9d4ac337-5f4d-ef47-e053-2a95a90a6dbf2025-01-08Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLCacff4ff3-4435-4995-a117-dbfcdf72334a2024-12-15Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLC8b1cdee5-3368-40e4-90bf-31a64df1f38a2024-12-12Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
VentrixylFOLIC ACIDPureTek Corporationc29dc729-93be-2a20-e053-2a95a90a8ca32024-12-03Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Folitin-ZFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb141ac2-e5df-4df4-e053-2995a90a6e722024-12-02Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
FoliflexFERROUS FUMARATE, FOLIC ACIDPureTek Corporationcba98d1a-8cf9-39d9-e053-2995a90ae8bb2024-11-27Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.9c37fd25-2143-410c-8d89-d39aa5c7b4532024-11-22Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
PrenatrylFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb364551b-2ccc-4db3-e053-2995a90afbbf2024-10-08Boxed warning, Adverse reactionsExact identifier
unii: P6YC3EG204
PrenatrixFERROUS FUMARATE, FOLIC ACIDPureTek Corporationae07585b-e6e4-fd6d-e053-2995a90a7eec2024-09-30Boxed warning, Adverse reactionsExact identifier
unii: P6YC3EG204
PretrateFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba4a1424-0782-77c0-e053-2a95a90a6e442024-09-30Boxed warning, Adverse reactionsExact identifier
unii: P6YC3EG204
DexatranMULTIVITAMINPureTek Corporatione052d2c2-7a3f-37be-e053-2a95a90af21c2024-09-13Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
DavimetMULTIVITAMINPureTek Corporatione4a57710-caa9-51e5-e053-2a95a90a8ad02024-09-13Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.c6436212-9246-4e29-8540-9af992b667eb2024-06-03Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Occuloplex IEUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENEBioActive Nutritional, Inc.c2c9b577-4f75-4ddc-815f-46c3bb9b46d22024-05-08WarningsExact identifier
unii: P6YC3EG204
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst15c4de10-c059-8c2f-e063-6394a90a03a32024-04-10Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
NascobalCYANOCOBALAMINPar Health USA, LLC697e0e52-c01b-4b53-9994-f79c46eb6b4f2024-03-01Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: P6YC3EG204
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: P6YC3EG204

Reported adverse events (FAERS/openFDA)#

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