FDA.reportPublic FDA data

Calcium Gluconate

Manufacturer
Nova-Tech, Inc.
Effective date
2020-03-19
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:44

Label at a glance#

ProductCalcium Gluconate
Active ingredientCALCIUM GLUCONATE
Label structure8 sections

Storage and handling

Store between 15°C-30°C (59°F-86°F).

Label contents#

Full prescribing information#

INDICATIONS

INDICATIONS & USAGE SECTION

For use in cattle as an aid in treating uncomplicated milk fever (parturient paresis).

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For intravenous administration only.

Cattle ........... 250-500 mL

Dosage may be repeated at 8 to 12 hour intervals if required.

PRECAUTIONS SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Manufactured by:

Nova-Tech Inc.

Grand Island, NE 68801 USA

18-802

RMS 92-326

NDC# 65207-802-50

Nova-Tech® Animal Health

Calcium Gluconate 23%

Sterile Solution

Net Contents:

500 mL (16.91 fl oz)

Assembled in USA

Lot No. 

Exp. Date

Each 500 mL Contains

OTC - ACTIVE INGREDIENT SECTION

Calcium Gluconate ............................. 23% w/v

 (provides 10.71 g of Calcium* per 500 mL)

Water for Injection ............................ q.s.

*Present as salts or boryl esters of gluconic acid.

STORAGE AND HANDLING SECTION

Store between 15°C-30°C (59°F-86°F).

GENERAL PRECAUTIONS SECTION

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL label500 mL label500 mL label500 mL label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010723calcium gluconate 23 % Injectable SolutionPSN1
1010723calcium gluconate 230 MG/ML Injectable SolutionSCD1
1010723calcium gluconate 23 % Injectable SolutionSY1
1010723calcium gluconate 23 GM in 100 ML Injectable SolutionSY1
1010723calcium gluconate 230 MG/ML (calcium 10.7 GM in 500 ML) Injectable SolutionSY1
1010723calcium gluconate 230 MG/ML (calcium 21.4 MG/ML) Injectable SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65207-802-50Calcium Gluconate500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65207-802CALCIUM GLUCONATE INJECTION, SOLUTION [NOVA-TECH, INC.]11 package rows20200320_ca1456b2-929e-4294-be79-7ff88ed5c980.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65207-80265207-802-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM GLUCONATESQE6VB453KACTIB

Source Document#

Source XML

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium gluconateCALCIUM GLUCONATEREMEDYREPACK INC.d6db3a1c-ed02-48fc-9134-ea1d58acf42e2026-09-08Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited787603c6-3f50-473a-8e3b-71dcf6d869642026-06-23Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.3cbf6bf7-2415-4435-b3df-41855514a05d2025-12-23Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.841ea51f-dc0d-45ed-8b55-bb64640cb9302025-11-03Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEREMEDYREPACK INC.4c635f60-7868-46d5-b932-d5cf8fc844322025-09-29Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEProPharma Distribution38413366-b558-7dd0-e063-6394a90acb7e2025-07-18Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATESomerset Therapeutics, LLCfb40eba7-04e5-40dc-8a95-5f45e7bd70bc2025-02-06Warnings, Adverse reactionsName fallback
brand name: CALCIUM GLUCONATE
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b2024-08-21Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC7f5101e0-abf9-4fcf-8986-c799e33334342024-05-06Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited8ee79b4c-21d3-4742-ae37-e2f5629177062024-04-18Warnings, Adverse reactionsName fallback
brand name: CALCIUM GLUCONATE
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst788ab6d7-d80c-0220-e053-2991aa0ae6e92024-02-01Warnings, Adverse reactionsName fallback
brand name: CALCIUM GLUCONATE
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.8ec4d137-1e9b-40e2-aeb2-8f62626a8fa52023-09-01Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.ce7becd8-cf59-4470-aac8-82761a24ebd72023-09-01Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.313a4ea9-178b-495e-9bc7-af1860fa65012023-05-26Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEMedical Purchasing Solutions, LLCb6226367-b061-eec5-e053-2a95a90a617d2023-05-04Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEB. Braun Medical Inc.af362bcb-7010-4eb5-b8c4-42aa3b0cdcde2023-04-28Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE

Reported adverse events (FAERS/openFDA)#

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