Is there a generic for Dextrose; potassium chloride; sodium chloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Dextrose; potassium chloride; sodium chloride, referencing the brand POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dextrose; potassium chloride; sodium chloride?

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (NDA 019691, OTSUKA ICU MEDCL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dextrose; potassium chloride; sodium chloride are approved?

Dextrose; potassium chloride; sodium chloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Dextrose; potassium chloride; sodium chloride

Dextrose; potassium chloride; sodium chloride is approved as 10 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · NDA 019691

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×9	OTSUKA ICU MEDCL	NDA 019691	—	Mar 24, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERRLD×9	OTSUKA ICU MEDCL	NDA 018365	—	Jul 05, 1983
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERRLD×9	OTSUKA ICU MEDCL	NDA 018362	AP	Jul 05, 1983
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER×53	B BRAUN	NDA 019630	—	Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER×9	ICU MEDICAL INC	NDA 018876	—	Jan 17, 1986
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×7	BAXTER HLTHCARE	NDA 019308	—	Apr 05, 1985
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ×9	BAXTER HLTHCARE	NDA 018037	AP	Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER×8	BAXTER HLTHCARE	NDA 018629	AP	Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%×12	B BRAUN	NDA 018268	—	Approved Prior to Jan 1, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER×10	BAXTER HLTHCARE	NDA 018008	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER×2	FRESENIUS KABI USA	ANDA 212348	AP	Jul 30, 2021
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%×5	FRESENIUS KABI USA	ANDA 213523	AP	Mar 09, 2021
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%×2	FRESENIUS KABI USA	ANDA 213445	AP	Mar 09, 2021

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Dextrose; potassium chloride; sodium chloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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