FDA Orange Book

Generic for Bethkis

Bethkis contains tobramycin. 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 Bethkis is tobramycin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.

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Bethkis products in the Orange Book

Bethkis products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, inhalation	300MG/4ML	Marketed (Rx)	AN	1	AN

NDA 201820, held by CHIESI USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tobramycin

Approved generic versions of Bethkis
Company	ANDA	TE code	Approved	Strengths
MANKIND PHARMA LTD	216725	AN (A-rated, therapeutically equivalent)	September 22, 2022	300MG/4ML

Bethkis NDC codes

Questions

Is there a generic for Bethkis?

Yes. The generic name for Bethkis is tobramycin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.

What is the generic name for Bethkis?

The active ingredient in Bethkis is tobramycin, 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.