FDA Orange Book

Is there a generic for Thyro-tabs?

Thyro-tabs contains levothyroxine. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Thyro-tabs (levothyroxine).

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Thyro-tabs products in the Orange Book

Thyro-tabs products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral0.025MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.05MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.075MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.088MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.112MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.137MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.175MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None
tablet, oral0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Marketed (Rx)AB1,AB2,AB3,AB40None

NDA 021116, held by ALVOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Thyro-tabs NDC codes

Questions

Is there a generic for Thyro-tabs?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Thyro-tabs (levothyroxine).

What is the generic name for Thyro-tabs?

The active ingredient in Thyro-tabs is levothyroxine, 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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