Last Updated: November 8, 2026

Details for New Drug Application (NDA): 219619

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NDA 219619 describes CALCIUM GLUCONATE IN SODIUM CHLORIDE, which is a drug marketed by Amneal, Cipla, Fresenius Kabi Usa, Hq Spclt Pharma, Milla Pharms, and Sagent, and is included in six NDAs. It is available from eight suppliers. There are two patents protecting this drug. Additional details are available on the CALCIUM GLUCONATE IN SODIUM CHLORIDE profile page.

The generic ingredient in CALCIUM GLUCONATE IN SODIUM CHLORIDE 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 219619

Tradename:	CALCIUM GLUCONATE IN SODIUM CHLORIDE
Applicant:	Sagent
Ingredient:	calcium gluconate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/50ML (20MG/ML)
Approval Date:	Dec 30, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	2GM/100ML (20MG/ML)
Approval Date:	Dec 30, 2025	TE:	AP	RLD:	No

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