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 6 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: P6YC3EG204
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst953aa8c6-31ce-0c3b-e053-2a95a90ab35f2024-01-30Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: P6YC3EG204
Quflora PediatricVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDECarWin Pharmaceutical Associates, LLCb8e08798-d8bb-4616-996b-a2c07a5d730a2024-01-10Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
TriStart DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENTCarWin Pharmaceutical Associates, LLC92ccf7d4-4527-49f0-b890-1a11b5a100862024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINHikma Pharmaceuticals USA Inc.a66eb3c4-3e1d-4d49-b963-4fa2334cc9b62023-12-01Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINAmerican Regent, Inc.2fb653d6-e2b2-4969-831b-c0dc37b9c0cc2023-10-31Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINAsclemed USA, Inc.071f7c95-7243-4014-b336-db8962ac0f752023-10-03Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINLupin Pharmaceuticals,Inc.efb7dc02-f0c9-4537-9e23-b641c428068c2023-08-24Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
cyanocobalaminCYANOCOBALAMINPadagis Israel Pharmaceuticals Ltd971e5f30-55c2-4193-9dd8-b43a1862b92a2023-02-28Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINSagent Pharmaceuticals7e10c47d-1036-47c1-a0ed-6929636366c22023-02-15Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Vitrexyl plus IronFERROUS FUMARATE, FOLIC ACIDPureTek Corporationada43056-a3ce-e7de-e053-2a95a90aa0462023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
PureVit DualFe PlusFERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEXPureTek Corporation71f63741-cad4-43b5-bb3e-c63a188d10a22023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
VitrexylFOLIC ACIDPureTek Corporationae064a9e-daba-fa86-e053-2a95a90a16a72023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Vitranol FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb81daf17-430b-6ba2-e053-2a95a90a768b2023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
VitrexateFOLIC ACIDPureTek Corporationb34fee43-bea9-45b7-e053-2a95a90aad4d2023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Vitrexate FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb3637def-a701-673a-e053-2995a90a02d52023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
VenexaFOLIC ACIDPureTek Corporationba130779-cdfd-086d-e053-2a95a90a25902023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Venexa FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba142128-21c4-4204-e053-2a95a90ae0d72023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Ribotin-EFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfcd-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204

Reported adverse events (FAERS/openFDA)#

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