FDA Orange Book
Generic for Lopressor
Lopressor 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 Lopressor is metoprolol. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 3 of the 9 Lopressor products the Orange Book lists.
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Lopressor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 7 | AP |
| solution, oral | 10MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 100MG TARTRATE | Discontinued | None | 0 | None |
| tablet, extended release, oral | EQ 200MG TARTRATE | Discontinued | None | 0 | None |
| tablet, extended release, oral | EQ 300MG TARTRATE | Discontinued | None | 0 | None |
| tablet, extended release, oral | EQ 400MG TARTRATE | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 12.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | AB | 8 | AB |
NDA 018704, 219373, 019786, 017963, 218698, held by NOVARTIS PHARMACEUTICALS CORP. 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 |
|---|---|---|---|---|
| ADAPTIS PHARMA PRIVATE LTD | 074453 | AB (A-rated, therapeutically equivalent) | April 27, 1995 | 100MG, 50MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 074644 | AB (A-rated, therapeutically equivalent) | December 10, 1996 | 100MG, 50MG |
| HIKMA PHARMACEUTICALS USA INC | 076495 | AP (A-rated, therapeutically equivalent) | July 7, 2003 | 1MG/ML |
| MYLAN PHARMACEUTICALS INC | 076704 | AB (A-rated, therapeutically equivalent) | January 16, 2004 | 100MG, 50MG |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 077761 | AP (A-rated, therapeutically equivalent) | May 30, 2007 | 1MG/ML |
| AUROBINDO PHARMA LTD | 077739 | AB (A-rated, therapeutically equivalent) | September 11, 2007 | 100MG, 50MG |
| SANDOZ INC | 077360 | AP (A-rated, therapeutically equivalent) | October 2, 2007 | 1MG/ML |
| HOSPIRA INC | 078085 | AP (A-rated, therapeutically equivalent) | April 29, 2008 | 1MG/ML |
| IPCA LABORATORIES LTD | 078459 | AB (A-rated, therapeutically equivalent) | June 17, 2008 | 100MG, 50MG |
| FRESENIUS KABI USA LLC | 091045 | AP (A-rated, therapeutically equivalent) | October 25, 2010 | 1MG/ML |
| BAXTER HEALTHCARE CORP | 078950 | AP (A-rated, therapeutically equivalent) | April 29, 2013 | 1MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 202871 | AB (A-rated, therapeutically equivalent) | May 28, 2013 | 100MG, 50MG |
| GLAND PHARMA LTD | 204205 | AP (A-rated, therapeutically equivalent) | August 27, 2014 | 1MG/ML |
| RUBICON RESEARCH LTD | 200981 | AB (A-rated, therapeutically equivalent) | October 28, 2014 | 100MG, 50MG |
| SCIEGEN PHARMACEUTICALS INC | 208955 | AB (A-rated, therapeutically equivalent) | February 5, 2020 | 100MG, 50MG |
Lopressor NDC codes
Questions
Is there a generic for Lopressor?
Yes. The generic name for Lopressor is metoprolol. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 3 of the 9 Lopressor products the Orange Book lists.
What is the generic name for Lopressor?
The active ingredient in Lopressor 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.
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