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

Lopressor products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection1MG/MLDiscontinuedNone7AP
solution, oral10MG/MLMarketed (Rx)None0None
tablet, extended release, oralEQ 100MG TARTRATEDiscontinuedNone0None
tablet, extended release, oralEQ 200MG TARTRATEDiscontinuedNone0None
tablet, extended release, oralEQ 300MG TARTRATEDiscontinuedNone0None
tablet, extended release, oralEQ 400MG TARTRATEDiscontinuedNone0None
tablet, oral100MGMarketed (Rx)AB8AB
tablet, oral12.5MGMarketed (Rx)None0None
tablet, oral50MGMarketed (Rx)AB8AB

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

Approved generic versions of Lopressor
CompanyANDATE codeApprovedStrengths
ADAPTIS PHARMA PRIVATE LTD074453AB (A-rated, therapeutically equivalent)April 27, 1995100MG, 50MG
SUN PHARMACEUTICAL INDUSTRIES INC074644AB (A-rated, therapeutically equivalent)December 10, 1996100MG, 50MG
HIKMA PHARMACEUTICALS USA INC076495AP (A-rated, therapeutically equivalent)July 7, 20031MG/ML
MYLAN PHARMACEUTICALS INC076704AB (A-rated, therapeutically equivalent)January 16, 2004100MG, 50MG
HIKMA FARMACEUTICA (PORTUGAL) SA077761AP (A-rated, therapeutically equivalent)May 30, 20071MG/ML
AUROBINDO PHARMA LTD077739AB (A-rated, therapeutically equivalent)September 11, 2007100MG, 50MG
SANDOZ INC077360AP (A-rated, therapeutically equivalent)October 2, 20071MG/ML
HOSPIRA INC078085AP (A-rated, therapeutically equivalent)April 29, 20081MG/ML
IPCA LABORATORIES LTD078459AB (A-rated, therapeutically equivalent)June 17, 2008100MG, 50MG
FRESENIUS KABI USA LLC091045AP (A-rated, therapeutically equivalent)October 25, 20101MG/ML
BAXTER HEALTHCARE CORP078950AP (A-rated, therapeutically equivalent)April 29, 20131MG/ML
ALEMBIC PHARMACEUTICALS LTD202871AB (A-rated, therapeutically equivalent)May 28, 2013100MG, 50MG
GLAND PHARMA LTD204205AP (A-rated, therapeutically equivalent)August 27, 20141MG/ML
RUBICON RESEARCH LTD200981AB (A-rated, therapeutically equivalent)October 28, 2014100MG, 50MG
SCIEGEN PHARMACEUTICALS INC208955AB (A-rated, therapeutically equivalent)February 5, 2020100MG, 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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