FDA Orange Book
Generic for Reglan
Reglan 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 is metoclopramide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP. Generics match 4 of the 5 Reglan products the Orange Book lists.
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Reglan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10MG BASE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 5MG BASE/ML | Discontinued | None | 5 | AP |
| solution, oral | EQ 5MG BASE/5ML | Discontinued | None | 2 | AA |
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | AB | 4 | AB |
NDA 017862, 018821, 017854, held by HIKMA PHARMACEUTICALS USA 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 070184 | AB (A-rated, therapeutically equivalent) | July 29, 1985 | EQ 10MG BASE |
| AIPING PHARMACEUTICAL INC | 072215 | AB (A-rated, therapeutically equivalent) | January 30, 1990 | EQ 10MG BASE, EQ 5MG BASE |
| HOSPIRA INC | 073118 | AP (A-rated, therapeutically equivalent) | January 17, 1991 | EQ 5MG BASE/ML |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 072744 | AA (A-rated, therapeutically equivalent) | May 28, 1991 | EQ 5MG BASE/5ML |
| TEVA PHARMACEUTICALS USA | 073135 | AP (A-rated, therapeutically equivalent) | November 27, 1991 | EQ 5MG BASE/ML |
| TEVA PHARMACEUTICALS USA INC | 072801 | AB (A-rated, therapeutically equivalent) | June 15, 1993 | EQ 5MG BASE |
| ANI PHARMACEUTICALS INC | 071402 | AA (A-rated, therapeutically equivalent) | June 25, 1993 | EQ 5MG BASE/5ML |
| STRIDES PHARMA INTERNATIONAL AG | 077878 | AB (A-rated, therapeutically equivalent) | August 28, 2006 | EQ 10MG BASE, EQ 5MG BASE |
| IPCA LABORATORIES LTD | 078807 | AB (A-rated, therapeutically equivalent) | June 12, 2008 | EQ 10MG BASE, EQ 5MG BASE |
| FRESENIUS KABI USA LLC | 091392 | AP (A-rated, therapeutically equivalent) | April 19, 2013 | EQ 5MG BASE/ML |
| AVET LIFESCIENCES LTD | 204756 | AP (A-rated, therapeutically equivalent) | December 20, 2013 | EQ 5MG BASE/ML |
| BAXTER HEALTHCARE CORP | 217072 | AP (A-rated, therapeutically equivalent) | September 11, 2026 | EQ 5MG BASE/ML |
Reglan NDC codes
Questions
Is there a generic for Reglan?
Yes. The generic name for Reglan is metoclopramide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP. Generics match 4 of the 5 Reglan products the Orange Book lists.
What is the generic name for Reglan?
The active ingredient in Reglan 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.
More on Reglan and Metoclopramide
- What is Metoclopramide used for?FDA label uses
- Is Metoclopramide a controlled substance?Federal schedule
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- Generic for Reglan ODTFDA Orange Book
- Dopamine-2 Receptor Antagonists listFDA drug class
- NDC 62559-165Reglan NDC record
- NDC 62559-166Reglan NDC record