FDA Orange Book

Generic for Metozolv ODT

Metozolv ODT contains metoclopramide. 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 Metozolv ODT is metoclopramide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Metozolv ODT products in the Orange Book

Metozolv ODT products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, orally disintegrating, oralEQ 10MG BASEDiscontinuedNone1None
tablet, orally disintegrating, oralEQ 5MG BASEDiscontinuedNone1None

NDA 022246, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic metoclopramide

Approved generic versions of Metozolv ODT
CompanyANDATE codeApprovedStrengths
NOVEL LABORATORIES INC202191None (No TE code listed)August 15, 2014EQ 10MG BASE, EQ 5MG BASE

Questions

Is there a generic for Metozolv ODT?

Yes. The generic name for Metozolv ODT is metoclopramide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Metozolv ODT?

The active ingredient in Metozolv ODT is metoclopramide, 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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