FDA Orange Book
Generic for Reglan ODT
Reglan 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 Reglan ODT is metoclopramide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Reglan ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | EQ 10MG BASE | Discontinued | None | 1 | None |
| tablet, orally disintegrating, oral | EQ 5MG BASE | Discontinued | None | 1 | None |
NDA 021793, held by MEDA 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 202191 | None (No TE code listed) | August 15, 2014 | EQ 10MG BASE, EQ 5MG BASE |
Questions
Is there a generic for Reglan ODT?
Yes. The generic name for Reglan 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 Reglan ODT?
The active ingredient in Reglan 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.