FDA Orange Book
Generic for Elavil
Elavil contains amitriptyline. 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 Elavil is amitriptyline. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Elavil products the Orange Book lists.
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Elavil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 11 | AB |
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 150MG | Discontinued | None | 11 | AB |
| tablet, oral | 25MG | Discontinued | None | 11 | AB |
| tablet, oral | 50MG | Discontinued | None | 11 | AB |
| tablet, oral | 75MG | Discontinued | None | 11 | AB |
NDA 012704, 012703, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amitriptyline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 089399 | AB (A-rated, therapeutically equivalent) | July 14, 1987 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| ACCORD HEALTHCARE INC | 202446 | AB (A-rated, therapeutically equivalent) | June 4, 2014 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| ZYDUS PHARMACEUTICALS USA INC | 210086 | AB (A-rated, therapeutically equivalent) | October 6, 2017 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| MANKIND PHARMA LTD | 213999 | AB (A-rated, therapeutically equivalent) | February 19, 2021 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| UNICHEM LABORATORIES LTD | 214548 | AB (A-rated, therapeutically equivalent) | May 19, 2021 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| AIPING PHARMACEUTICAL INC | 212654 | AB (A-rated, therapeutically equivalent) | September 29, 2021 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| RUBICON RESEARCH LTD | 215376 | AB (A-rated, therapeutically equivalent) | May 1, 2023 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| RISING PHARMA HOLDINGS INC | 217411 | AB (A-rated, therapeutically equivalent) | May 19, 2023 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| UNIQUE PHARMACEUTICAL LABORATORIES | 218389 | AB (A-rated, therapeutically equivalent) | June 23, 2025 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| AUROBINDO PHARMA USA INC | 086009 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
| SANDOZ INC | 085968 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 100MG, 10MG, 150MG, 25MG, 50MG, 75MG |
Questions
Is there a generic for Elavil?
Yes. The generic name for Elavil is amitriptyline. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Elavil products the Orange Book lists.
What is the generic name for Elavil?
The active ingredient in Elavil is amitriptyline, 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.