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 7 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
unii: P6YC3EG204
cyanocobalaminCYANOCOBALAMINAsclemed USA, Inc.d589cc00-a896-4a6b-b93c-a049c8af69732022-10-12Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.ccf5b124-083d-4465-a666-c1bc6e84d6302022-04-29Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
cyanocobalaminCYANOCOBALAMINZydus Pharmaceuticals USA Inc.e6712877-ace0-441c-99a9-adf567c0b9a22022-04-25Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
cyanocobalaminCYANOCOBALAMINZydus Lifesciences Limitedef300a08-8212-40a9-847a-1b62348896dd2022-04-19Exact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINAuroMedics Pharma LLCdb84d0ea-5c15-47f5-bbe2-8d455e75695e2022-03-10Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINAsclemed USA, Inc.66e3441f-79fa-4a1b-be22-2bc683cd7abc2021-07-08Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204

Reported adverse events (FAERS/openFDA)#

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