FDA.reportPublic FDA data

NDC 50989-031 - AMCALCILYTE FORTE

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
50989-031
Package NDCs from labels
50989-031-17
Manufacturer
Vedco, Inc.
Effective date
2017-06-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMCALCILYTE FORTEVedco, Inc.2017-06-21OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50989-031-17AMCALCILYTE FORTE1000 mL in 1 BOTTLESOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50989-031AMCALCILYTE FORTE (AMCALCILYTE) SOLUTION [VEDCO, INC.]11 package rows20240605_dc3c4a4c-60a6-4e80-a51c-d63743c906e0.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 41 of 63 · 1,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAmerican Health Packaging8c12c5f8-5950-44e3-9473-a0b95187b43c2024-08-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLC1373321f-533a-4ab4-8bcd-8bde15371a092024-08-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack7427c29e-55c1-4c30-b091-058c8bec592f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf1791d4f-029a-487f-aee1-fc5be246d0bc2024-08-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack80dd5de2-5066-472b-b1f8-88070a5c73882024-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMBioActive Nutritional, Inc.7920e8f6-be48-4402-9085-9673779db5a22024-07-31WarningsExact identifier
unii: 660YQ98I10
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEFresenius Kabi USA, LLC3849b89c-c309-46fb-a1e2-53ff0c65077f2024-07-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepack7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb2024-07-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackb5a6b6f2-d073-4bd3-a66c-bf34ccabfe512024-07-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WINTER BLENDECHINACEA (ANGUSTIFOLIA), UVA-URSI, BAPTISIA TINCTORIA, CONVALLARIA MAJALIS, KALI MURIATICUM, PINUS SYLVESTRIS, THUJA OCCIDENTALIS, BRYONIA, CROTALUS HORRIDUS, LACHESIS MUTUS, SELENIUM METALLICUM, VISCUM ALBUMEnergique, Inc.ff696389-bad5-463a-be99-e92e86250e862024-07-12WarningsExact identifier
unii: 660YQ98I10
Potassium PhosphatePOTASSIUM PHOSPHATESomerset Therapeutics, LLC52f07402-1869-4a97-9c92-9729dc611f852024-07-11Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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