FDA.reportPublic FDA data

NDC 65219-162-01 - Calcium Gluconate

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
65219-162
Requested NDC
65219-162-01
Package NDCs from labels
65219-162-01, 65219-162-10
Manufacturer
Fresenius Kabi USA, LLC | HP Halden Pharma AS
Effective date
2024-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Calcium Gluconate - Fresenius Kabi USA, LLC | HP Halden Pharma ASFresenius Kabi USA, LLC | HP Halden Pharma AS2024-05-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-162-01Calcium Gluconate50 mL in 1 BAGINJECTION, SOLUTION504
65219-162-10Calcium Gluconate24 in 1 CASEINJECTION, SOLUTION244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-162CALCIUM GLUCONATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20240509_7f5101e0-abf9-4fcf-8986-c799e3333434.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-162-01ML - Milliliter65219-16207a1d859-a2fe-41f8-a367-336b1577ea6b12022-05-04
65219-162-10ML - Milliliter65219-162bc9b176d-383e-4404-a2e5-06fbc64dfe2512022-05-04

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 4 of 46 · 906 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts DIGESTIVE BALANCENAT MUR, NAT PHOS, NAT SULPHZettl Health Inc.54018d0e-372f-8afc-e063-6394a90aeb152026-06-11WarningsExact identifier
unii: 451W47IQ8X
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsExact identifier
unii: CZN0MI5R31
GUNA-ALLERGY TAMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA -Guna spafddba85e-2bec-468f-a01a-b71a3aeed9d32026-06-10WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d48847-c0bf-1334-e063-6294a90acf7e2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53d52b7e-1e84-d4d3-e063-6294a90a9efc2026-06-09WarningsExact identifier
unii: 451W47IQ8X
ApizelenGERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUMBioActive Nutritional, Inc.471a7fab-1ef1-4d13-a28e-75f9762a711a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsExact identifier
application number: NDA208418
unii: CZN0MI5R31
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsExact identifier
unii: CZN0MI5R31
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsExact identifier
unii: CZN0MI5R31

Reported adverse events (FAERS/openFDA)#

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