Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216611


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NDA 216611 describes CALCIUM GLUCONATE, which is a drug marketed by Amneal, B Braun Medical, Caplin, Fresenius Kabi Usa, Hq Spclt Pharma, Nivagen Pharms Inc, Somerset, and Sagent, and is included in nine NDAs. It is available from thirteen suppliers. There are two patents protecting this drug. Additional details are available on the CALCIUM GLUCONATE profile page.

The generic ingredient in CALCIUM GLUCONATE is calcium gluconate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the calcium gluconate profile page.
Summary for 216611
Tradename:CALCIUM GLUCONATE
Applicant:Amneal
Ingredient:calcium gluconate
Patents:0
Pharmacology for NDA: 216611
Mechanism of ActionPhosphate Chelating Activity
Physiological EffectIncreased Coagulation Factor Activity
Suppliers and Packaging for NDA: 216611
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611 ANDA Amneal Pharmaceuticals Private Limited 80830-1672 80830-1672-2 10 VIAL in 1 CARTON (80830-1672-2) / 10 mL in 1 VIAL (80830-1672-1)
CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611 ANDA Amneal Pharmaceuticals Private Limited 80830-1672 80830-1672-5 25 VIAL in 1 CARTON (80830-1672-5) / 10 mL in 1 VIAL (80830-1672-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1GM/10ML (100MG/ML)
Approval Date:May 10, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5GM/50ML (100MG/ML)
Approval Date:May 10, 2024TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10GM/100ML (100MG/ML)
Approval Date:May 10, 2024TE:APRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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