FDA.reportPublic FDA data

NDC 58005-400 - VITAMIN B12

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
58005-400
Package NDCs from labels
58005-400-04, 58005-400-05, 58005-400-06
Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2011-07-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VITAMIN B12 INJECTIONSparhawk Laboratories, Inc.2011-07-26PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58005-400-04VITAMIN B12100 mL in 1 VIALINJECTION1002
58005-400-05VITAMIN B12250 mL in 1 VIALINJECTION2502
58005-400-06VITAMIN B12500 mL in 1 VIALINJECTION5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-400VITAMIN B12 (CYANOCOBALAMIN) INJECTION [SPARHAWK LABORATORIES, INC.]23 package rows20110727_bbd18241-be33-4090-a669-d599ca0f2fde.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204VITAMIN B12 (CYANOCOBALAMIN) INJECTION [SPARHAWK LABORATORIES, INC.]2
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204VITAMIN B12 (CYANOCOBALAMIN) INJECTION [SPARHAWK LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RVITAMIN B12 (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 14 of 15 · 295 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Ventrixyl FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationc7a626ec-88ec-d899-e053-2a95a90ab0ba2023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Zintrexyl-CFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfca-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Telomere - DNACA98, CAROTENOID, DNA, GLUTATHIONE, OMEGA 3, PITUITARUM, RNA, VITAMIN B COMPLEX, VITAMIN C, VITAMIN D3, VITAMIN EProBLENb093dfba-ed48-47a2-b4ce-f706221935a12022-11-30WarningsExact identifier
unii: P6YC3EG204
Concept DHAVITAMIN- MINERAL OMEGA-3 SUPPLEMENTU.S. Pharmaceutical Corporationbd2051f7-b887-46f6-8d4a-b099fcd086292022-11-08WarningsExact identifier
unii: P6YC3EG204
Concept OBVITAMIN MINERAL SUPPLEMENTU.S. Pharmaceutical Corporation37992a25-68bd-4050-b936-596ddedc25a32022-11-08Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINGland Pharma Limitedcd8d188a-fa5d-4580-bcb1-ac8617118cbb2022-11-02Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
cyanocobalaminCYANOCOBALAMINAsclemed USA, Inc.d589cc00-a896-4a6b-b93c-a049c8af69732022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.ccf5b124-083d-4465-a666-c1bc6e84d6302022-04-29Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
cyanocobalaminCYANOCOBALAMINZydus Pharmaceuticals USA Inc.e6712877-ace0-441c-99a9-adf567c0b9a22022-04-25Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
cyanocobalaminCYANOCOBALAMINZydus Lifesciences Limitedef300a08-8212-40a9-847a-1b62348896dd2022-04-19Exact identifier
rxcui: 309594
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINAuroMedics Pharma LLCdb84d0ea-5c15-47f5-bbe2-8d455e75695e2022-03-10Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204

Reported adverse events (FAERS/openFDA)#

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