FDA Orange Book
Generic for Toprol XL
Toprol XL contains metoprolol. 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 Toprol XL is metoprolol. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Toprol XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 100MG TARTRATE | Marketed (Rx) | AB | 15 | AB |
| tablet, extended release, oral | EQ 200MG TARTRATE | Marketed (Rx) | AB | 15 | AB |
| tablet, extended release, oral | EQ 25MG TARTRATE | Marketed (Rx) | AB | 14 | AB |
| tablet, extended release, oral | EQ 50MG TARTRATE | Marketed (Rx) | AB | 16 | AB |
NDA 019962, held by MELINTA THERAPEUTICS LLC A WHOLLY OWNED SUB OF CORMEDIX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metoprolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 076862 | AB (A-rated, therapeutically equivalent) | August 3, 2009 | EQ 50MG TARTRATE |
| WOCKHARDT BIO AG | 090615 | AB (A-rated, therapeutically equivalent) | July 22, 2010 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| DR REDDYS LABORATORIES LTD | 090617 | AB (A-rated, therapeutically equivalent) | August 1, 2012 | EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| DOCTOR REDDYS LABORATORIES LTD | 078889 | AB (A-rated, therapeutically equivalent) | August 15, 2012 | EQ 100MG TARTRATE, EQ 200MG TARTRATE |
| ACTAVIS ELIZABETH LLC | 204161 | AB (A-rated, therapeutically equivalent) | November 25, 2016 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| NOVAST LABORATORIES LTD | 204106 | AB (A-rated, therapeutically equivalent) | February 6, 2018 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| ZYDUS PHARMACEUTICALS USA INC | 203894 | AB (A-rated, therapeutically equivalent) | March 23, 2018 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| CIPLA LTD | 207465 | AB (A-rated, therapeutically equivalent) | October 26, 2018 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 50MG TARTRATE |
| VISUM PHARMACEUTICAL CO LTD | 207206 | AB (A-rated, therapeutically equivalent) | December 19, 2018 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| ALICORA INC | 203699 | AB (A-rated, therapeutically equivalent) | March 30, 2020 | EQ 100MG TARTRATE, EQ 200MG TARTRATE |
| ALICORA INC | 203028 | AB (A-rated, therapeutically equivalent) | March 31, 2020 | EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| HETERO LABS LTD UNIT III | 205541 | AB (A-rated, therapeutically equivalent) | November 6, 2020 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| ALKEM LABORATORIES LTD | 211143 | AB (A-rated, therapeutically equivalent) | November 25, 2020 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 213854 | AB (A-rated, therapeutically equivalent) | February 12, 2021 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| SUNSHINE LAKE PHARMA CO LTD | 214004 | AB (A-rated, therapeutically equivalent) | September 26, 2022 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| GRANULES INDIA LTD | 216916 | AB (A-rated, therapeutically equivalent) | June 12, 2023 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | 214110 | AB (A-rated, therapeutically equivalent) | July 26, 2024 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
| IPCA LABORATORIES LTD | 206980 | AB (A-rated, therapeutically equivalent) | June 25, 2025 | EQ 100MG TARTRATE, EQ 200MG TARTRATE, EQ 25MG TARTRATE, EQ 50MG TARTRATE |
Toprol XL NDC codes
Questions
Is there a generic for Toprol XL?
Yes. The generic name for Toprol XL is metoprolol. 17 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 Toprol XL?
The active ingredient in Toprol XL is metoprolol, 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.
More on Toprol XL and Metoprolol
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- Is Toprol XL a controlled substance?Federal schedule
- What is Metoprolol used for?FDA label uses
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