FDA Orange Book
Generic for Levo-t
Levo-t 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 Levo-t 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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Levo-t products in the Orange Book
| 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 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,AB3 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
NDA 021342, held by CEDIPROF INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levothyroxine
| 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 |
Levo-t NDC codes
Questions
Is there a generic for Levo-t?
Yes. The generic name for Levo-t 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.
What is the generic name for Levo-t?
The active ingredient in Levo-t 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.