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 9 of 15 · 297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst9d4ac337-5f4d-ef47-e053-2a95a90a6dbf2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLCacff4ff3-4435-4995-a117-dbfcdf72334a2024-12-15Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLC8b1cdee5-3368-40e4-90bf-31a64df1f38a2024-12-12Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
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
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.9c37fd25-2143-410c-8d89-d39aa5c7b4532024-11-22Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204

Reported adverse events (FAERS/openFDA)#

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