FDA.reportPublic FDA data

Calcium Gluconate

Manufacturer
Covetrus
Effective date
2024-04-05
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:43:00

Label at a glance#

ProductCalcium Gluconate
Active ingredientCALCIUM GLUCONATE
Label structure9 sections

Dosage and administration

Administer to cattle 200-500 mL intravenously. Dosage may be repeated in 8 to 12 hour intervals as needed. Monitor animal's condition closely. Re-treatment may be necessary. If there is no noticeable improvement within 24 hours following treatment, consult your veterinarian. Aseptic precautions should be observed.

Storage and handling

Store between 15°-30°C (59°-86°F).

Label contents#

Full prescribing information#

INDICATIONS:

INDICATIONS & USAGE SECTION

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

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Administer to cattle 200-500 mL intravenously. Dosage may be repeated in 8 to 12 hour intervals as needed. Monitor animal's condition closely. Re-treatment may be necessary. If there is no noticeable improvement within 24 hours following treatment, consult your veterinarian. Aseptic precautions should be observed.

PRECAUTIONS SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS SECTION

NDC 11695-6411-5

Calcium gluconate 23%

Sterile Solution

Net Contents: 16.91 fl oz (500 mL)

Questions? (855) 724-3461

Reorder #069167

18-802

RMS 92-1174

Made in the USA

AH-069167-L-02

REV: 0523

Lot No.

Exp. Date

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Manufactured by:

Nova-Tech, Inc.

Grand Island, NE 68801

Composition:

OTC - ACTIVE INGREDIENT SECTION

Each 500 mL contains:

Active ingredients:

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

   (provides 10.71 g of Calcium* per 500 mL) 

   * Present as salts or boryl esters of gluconic acid.

Inactive ingredients:

Water for injection .................................. q.s.

   Contains boric acid as a solubilizing agent.

STORAGE AND HANDLING SECTION

Store between 15°-30°C (59°-86°F).

GENERAL PRECAUTIONS SECTION

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Caution:

PRECAUTIONS SECTION

Solution should be warmed to body temperature and administered slowly. Entire contents should be used upon opening, as this product contains no preservatives. Discard any unused portion. Do not use if solution is cloudy or contains precipitate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL label500 mL label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010723calcium gluconate 23 % Injectable SolutionPSN2
1010723calcium gluconate 230 MG/ML Injectable SolutionSCD2
1010723calcium gluconate 23 % Injectable SolutionSY2
1010723calcium gluconate 23 GM in 100 ML Injectable SolutionSY2
1010723calcium gluconate 230 MG/ML (calcium 10.7 GM in 500 ML) Injectable SolutionSY2
1010723calcium gluconate 230 MG/ML (calcium 21.4 MG/ML) Injectable SolutionSY2

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
11695-6411-5Calcium Gluconate500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11695-6411CALCIUM GLUCONATE INJECTION, SOLUTION [COVETRUS]21 package rows20240420_b02bc22b-2f48-4404-beb7-5b66f3b85e82.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
11695-641111695-6411-5

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.