FDA Orange Book

Generic for Synthroid

Synthroid 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

Yes. The generic name for Synthroid is levothyroxine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1,AB2,AB3, AB1,AB2,AB3,AB4, AB2, AB4.

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Synthroid products in the Orange Book

Synthroid products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2
tablet, oral	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Marketed (Rx)	AB1,AB2	7	AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2

NDA 021402, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic levothyroxine

Approved generic versions of Synthroid
Company	ANDA	TE code	Approved	Strengths
MYLAN PHARMACEUTICALS INC	076187	AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent)	June 5, 2002	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
LUPIN INC	209713	AB1,AB2,AB3 (A-rated, therapeutically equivalent)	January 18, 2019	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
ACCORD HEALTHCARE INC	212399	AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent)	October 19, 2020	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	207588	AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent)	May 10, 2022	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
MACLEODS PHARMACEUTICALS LTD	211417	AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent)	December 21, 2022	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
ASCENT PHARMACEUTICALS INC	215259	AB4 (A-rated, therapeutically equivalent)	January 18, 2023	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
ALEMBIC PHARMACEUTICALS LTD	216370	AB2 (A-rated, therapeutically equivalent)	May 20, 2026	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Synthroid NDC codes

Questions

Is there a generic for Synthroid?

What is the generic name for Synthroid?

The active ingredient in Synthroid 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.