FDA Orange Book

Generic for Cytomel

Cytomel contains liothyronine. 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 Cytomel is liothyronine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Cytomel products in the Orange Book

Cytomel products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 0.005MG BASEMarketed (Rx)AB6AB
tablet, oralEQ 0.025MG BASEMarketed (Rx)AB6AB
tablet, oralEQ 0.05MG BASEMarketed (Rx)AB6AB

NDA 010379, held by KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic liothyronine

Approved generic versions of Cytomel
CompanyANDATE codeApprovedStrengths
DR REDDYS LABORATORIES SA090097AB (A-rated, therapeutically equivalent)March 20, 2009EQ 0.005MG BASE, EQ 0.025MG BASE, EQ 0.05MG BASE
SIGMAPHARM LABORATORIES LLC200295AB (A-rated, therapeutically equivalent)November 29, 2012EQ 0.005MG BASE, EQ 0.025MG BASE, EQ 0.05MG BASE
SUN PHARMACEUTICAL INDUSTRIES LTD091382AB (A-rated, therapeutically equivalent)April 20, 2016EQ 0.005MG BASE, EQ 0.025MG BASE, EQ 0.05MG BASE
TEVA PHARMACEUTICALS USA INC211510AB (A-rated, therapeutically equivalent)October 26, 2018EQ 0.005MG BASE, EQ 0.025MG BASE, EQ 0.05MG BASE
ZYDUS LIFESCIENCES GLOBAL FZE214803AB (A-rated, therapeutically equivalent)January 22, 2021EQ 0.005MG BASE, EQ 0.025MG BASE, EQ 0.05MG BASE
BIOCON PHARMA INC218070AB (A-rated, therapeutically equivalent)February 6, 2024EQ 0.005MG BASE, EQ 0.025MG BASE, EQ 0.05MG BASE

Cytomel NDC codes

Questions

Is there a generic for Cytomel?

Yes. The generic name for Cytomel is liothyronine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Cytomel?

The active ingredient in Cytomel is liothyronine, 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.

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