FDA Orange Book

Generic for Duraclon

Duraclon contains clonidine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Duraclon is clonidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Duraclon products in the Orange Book

Duraclon products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	1MG/10ML (0.1MG/ML)	Marketed (Rx)	AP	4	AP
injectable, injection	5MG/10ML (0.5MG/ML)	Discontinued	None	4	AP

NDA 020615, held by MYLAN INSTITUTIONAL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic clonidine

Approved generic versions of Duraclon
Company	ANDA	TE code	Approved	Strengths
HIKMA FARMACEUTICA (PORTUGAL) SA	200300	AP (A-rated, therapeutically equivalent)	January 26, 2011	1MG/10ML (0.1MG/ML), 5MG/10ML (0.5MG/ML)
FRESENIUS KABI USA LLC	200673	AP (A-rated, therapeutically equivalent)	July 8, 2011	1MG/10ML (0.1MG/ML), 5MG/10ML (0.5MG/ML)
XGEN PHARMACEUTICALS DJB INC	203167	AP (A-rated, therapeutically equivalent)	October 29, 2013	1MG/10ML (0.1MG/ML), 5MG/10ML (0.5MG/ML)
ZYDUS PHARMACEUTICALS USA INC	202601	AP (A-rated, therapeutically equivalent)	February 20, 2014	1MG/10ML (0.1MG/ML), 5MG/10ML (0.5MG/ML)

Duraclon NDC codes

67457-218

Questions

Is there a generic for Duraclon?

Yes. The generic name for Duraclon is clonidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Duraclon?

The active ingredient in Duraclon is clonidine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.