FDA.reportPublic FDA data

NDC 57319-502 - Vitamin B12 1000 mcg

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
57319-502
Package NDCs from labels
57319-502-05, 57319-502-06
Manufacturer
Clipper Distributing Company LLC
Effective date
2018-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vitamin B12 1000 mcg - Clipper Distributing Company LLCClipper Distributing Company LLC2018-03-20PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-502-05Vitamin B121000 mcg100 mL in 1 VIALINJECTION, SOLUTION1001
57319-502-06Vitamin B121000 mcg250 mL in 1 VIALINJECTION, SOLUTION2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-502VITAMIN B12 1000 MCG (CYANOCOBALAMIN) INJECTION, SOLUTION [CLIPPER DISTRIBUTING COMPANY LLC]12 package rows20180320_0a8e5468-7a87-4a3b-a000-90cdb4806ccf.zip

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 · 288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
unii: P6YC3EG204
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CyanocobalaminCYANOCOBALAMINAsclemed USA, Inc.66e3441f-79fa-4a1b-be22-2bc683cd7abc2021-07-08Warnings, Adverse reactionsExact identifier
rxcui: 309594
unii: P6YC3EG204
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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