FDA Orange Book

Generic for Aralen

Aralen contains chloroquine. 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 Aralen is chloroquine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Aralen products in the Orange Book

Aralen products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	500MG	Discontinued	None	3	AA

NDA 006002, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic chloroquine

Approved generic versions of Aralen
Company	ANDA	TE code	Approved	Strengths
IMPAX LABORATORIES INC	040516	AA (A-rated, therapeutically equivalent)	August 29, 2003	500MG
NATCO PHARMA LTD	090612	AA (A-rated, therapeutically equivalent)	January 21, 2011	500MG
COHANCE LIFESCIENCES LTD	214756	AA (A-rated, therapeutically equivalent)	September 3, 2021	500MG

Questions

Is there a generic for Aralen?

Yes. The generic name for Aralen is chloroquine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

What is the generic name for Aralen?

The active ingredient in Aralen is chloroquine, 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.