FDA.reportPublic FDA data

NDC 80830-1674-03 - 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
80830-1674
Requested NDC
80830-1674-03
Package NDCs from labels
80830-1674-3, 80830-1674-8, 80830-1674-5, 80830-1674-2, 80830-1674-03
Manufacturer
Amneal Pharmaceuticals Private Limited
Effective date
2026-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
calcium gluconate - Amneal Pharmaceuticals Private LimitedAmneal Pharmaceuticals Private Limited2026-06-23HUMAN PRESCRIPTION DRUG LABEL
calcium gluconate - Amneal Pharmaceuticals Private Limited | Amneal Pharmaceuticals of New York, LLCAmneal Pharmaceuticals Private Limited | Amneal Pharmaceuticals of New York, LLC2026-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80830-1674-2calcium gluconate10 in 1 CARTONINJECTION103
80830-1674-5calcium gluconate25 in 1 CARTONINJECTION253
80830-1674-8calcium gluconate100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80830-1674CALCIUM GLUCONATE INJECTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]3Current NDC, 3 package rows20240513_13d7cfc9-ff7a-437e-8c21-d9709ac07d48.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80830-1674-2ML - Milliliter80830-16748e59fbc8-438a-4395-8ac9-02a623d77b3c12024-07-12
80830-1674-8ML - Milliliter80830-16746caf29e0-6ffd-41b9-8bdf-bf3d4c58133612024-08-12

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 1 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium gluconateCALCIUM GLUCONATEREMEDYREPACK INC.d6db3a1c-ed02-48fc-9134-ea1d58acf42e2026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 1668250
unii: CZN0MI5R31
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited787603c6-3f50-473a-8e3b-71dcf6d869642026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA216611
ndc (package): 80830-1674-3
ndc (package): 80830-1672-4
ndc (package): 80830-1673-4
ndc (product): 80830-1673
ndc (product): 80830-1674
ndc (product): 80830-1672
ndc11 (package): 80830167403
rxcui: 197435
rxcui: 1668248
rxcui: 1668250
spl id: 2a2f5cae-dd07-4027-9bfc-41e406e2a767
spl set id: 787603c6-3f50-473a-8e3b-71dcf6d86964
unii: CZN0MI5R31
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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