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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218036

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NDA 218036 describes LITHIUM CITRATE, which is a drug marketed by Hikma, Pai Holdings Pharm, Rubicon Research, and Sciegen Pharms Inc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the LITHIUM CITRATE profile page.

The generic ingredient in LITHIUM CITRATE is lithium citrate. There are fifteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.

Summary for 218036

Tradename:	LITHIUM CITRATE
Applicant:	Rubicon Research
Ingredient:	lithium citrate
Patents:	0

Pharmacology for NDA: 218036

Suppliers and Packaging for NDA: 218036

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	218036	ANDA	Precision Dose, Inc.	68094-077	68094-077-62	3 TRAY in 1 CASE (68094-077-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-077-59)
LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	218036	ANDA	REMEDYREPACK INC.	70518-4227	70518-4227-0	10 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	EQ 300MG CARBONATE/5ML
Approval Date:	Aug 14, 2023	TE:	AA	RLD:	No

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