FDA Orange Book
Generic for Zanaflex
Zanaflex contains tizanidine. 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 Zanaflex is tizanidine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zanaflex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 2MG BASE | Marketed (Rx) | AB | 9 | AB |
| capsule, oral | EQ 4MG BASE | Marketed (Rx) | AB | 10 | AB |
| capsule, oral | EQ 6MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | EQ 2MG BASE | Discontinued | None | 11 | AB |
| tablet, oral | EQ 4MG BASE | Marketed (Rx) | AB | 11 | AB |
NDA 021447, 020397, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tizanidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES INC | 076286 | AB (A-rated, therapeutically equivalent) | July 3, 2002 | EQ 2MG BASE, EQ 4MG BASE |
| EPIC PHARMA LLC | 076347 | AB (A-rated, therapeutically equivalent) | October 11, 2002 | EQ 2MG BASE, EQ 4MG BASE |
| RISING PHARMA HOLDING INC | 076354 | AB (A-rated, therapeutically equivalent) | March 28, 2003 | EQ 2MG BASE, EQ 4MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES INC | 076416 | AB (A-rated, therapeutically equivalent) | September 29, 2003 | EQ 2MG BASE, EQ 4MG BASE |
| TP ANDA HOLDINGS LLC | 076281 | AB (A-rated, therapeutically equivalent) | October 20, 2003 | EQ 2MG BASE, EQ 4MG BASE |
| AUROBINDO PHARMA USA INC | 076282 | AB (A-rated, therapeutically equivalent) | December 16, 2003 | EQ 2MG BASE, EQ 4MG BASE |
| APOTEX INC | 076533 | AB (A-rated, therapeutically equivalent) | January 16, 2004 | EQ 2MG BASE, EQ 4MG BASE |
| APOTEX INC | 078868 | AB (A-rated, therapeutically equivalent) | February 3, 2012 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| UNICHEM LABORATORIES LTD | 091283 | AB (A-rated, therapeutically equivalent) | November 28, 2012 | EQ 2MG BASE, EQ 4MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 208622 | AB (A-rated, therapeutically equivalent) | March 3, 2017 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| JUBILANT GENERICS LTD | 209605 | AB (A-rated, therapeutically equivalent) | August 4, 2017 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| CADILA HEALTHCARE LTD | 208187 | AB (A-rated, therapeutically equivalent) | March 9, 2018 | EQ 2MG BASE, EQ 4MG BASE |
| ALKEM LABORATORIES LTD | 211798 | AB (A-rated, therapeutically equivalent) | January 25, 2019 | EQ 2MG BASE, EQ 4MG BASE |
| INGENUS PHARMACEUTICALS LLC | 210267 | AB (A-rated, therapeutically equivalent) | March 12, 2019 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| CADILA PHARMACEUTICALS LTD | 210021 | AB (A-rated, therapeutically equivalent) | March 26, 2019 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| ALKEM LABORATORIES LTD | 212196 | AB (A-rated, therapeutically equivalent) | March 27, 2019 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 213223 | AB (A-rated, therapeutically equivalent) | January 13, 2020 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| AUROBINDO PHARMA LTD | 213544 | AB (A-rated, therapeutically equivalent) | March 24, 2020 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| RUBICON RESEARCH LTD | 213798 | AB (A-rated, therapeutically equivalent) | May 27, 2020 | EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE |
| PHARMAZONE | 213365 | AB (A-rated, therapeutically equivalent) | May 13, 2024 | EQ 4MG BASE, EQ 6MG BASE |
| RISING PHARMA HOLDINGS INC | 218920 | AB (A-rated, therapeutically equivalent) | August 7, 2024 | EQ 2MG BASE, EQ 4MG BASE |
Zanaflex NDC codes
Questions
Is there a generic for Zanaflex?
Yes. The generic name for Zanaflex is tizanidine. 19 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 Zanaflex?
The active ingredient in Zanaflex is tizanidine, 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.