Is there a generic for Ammonium chloride?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Ammonium chloride, referencing the brand AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ammonium chloride?

AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE (NDA 006580, MCGAW) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ammonium chloride are approved?

Ammonium chloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ammonium chloride

Ammonium chloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE · NDA 006580

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE	MCGAW	NDA 006580	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
AMMONIUM CHLORIDE IN PLASTIC CONTAINER	HOSPIRA	ANDA 088366	—	Jun 13, 1984
AMMONIUM CHLORIDE	ABBOTT	ANDA 083130	—	Approved Prior to Jan 1, 1982
AMMONIUM CHLORIDE	GD SEARLE LLC	ANDA 086205	—	Approved Prior to Jan 1, 1982
AMMONIUM CHLORIDE 2.14%	B BRAUN	ANDA 085734	—	Approved Prior to Jan 1, 1982

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.

Ammonium chloride — frequently asked questions

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

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