FDA Orange Book
Generic for Normodyne
Normodyne contains labetalol. 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 Normodyne is labetalol. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Normodyne products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 5MG/ML | Discontinued | None | 8 | AP |
| tablet, oral | 100MG | Discontinued | None | 12 | AB |
| tablet, oral | 200MG | Discontinued | None | 12 | AB |
| tablet, oral | 300MG | Discontinued | None | 12 | AB |
| tablet, oral | 400MG | Discontinued | None | 2 | AB |
NDA 018686, 018687, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic labetalol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HERITAGE PHARMA LABS INC | 074787 | AB (A-rated, therapeutically equivalent) | August 3, 1998 | 100MG, 200MG, 300MG, 400MG |
| WATSON LABORATORIES INC | 075133 | AB (A-rated, therapeutically equivalent) | August 3, 1998 | 100MG, 200MG, 300MG |
| AIPING PHARMACEUTICAL INC | 075113 | AB (A-rated, therapeutically equivalent) | August 4, 1998 | 100MG, 200MG, 300MG |
| HIKMA PHARMACEUTICALS USA INC | 075303 | AP (A-rated, therapeutically equivalent) | May 28, 1999 | 5MG/ML |
| INNOGENIX LLC | 075215 | AB (A-rated, therapeutically equivalent) | July 29, 1999 | 100MG, 200MG, 300MG |
| HOSPIRA INC | 075239 | AP (A-rated, therapeutically equivalent) | November 29, 1999 | 5MG/ML |
| HOSPIRA INC | 075240 | AP (A-rated, therapeutically equivalent) | November 29, 1999 | 5MG/ML |
| RISING PHARMA HOLDINGS INC | 075431 | AP (A-rated, therapeutically equivalent) | November 29, 1999 | 5MG/ML |
| BAXTER HEALTHCARE CORP | 076051 | AP (A-rated, therapeutically equivalent) | July 5, 2002 | 5MG/ML |
| GLAND PHARMA LTD | 090699 | AP (A-rated, therapeutically equivalent) | April 3, 2012 | 5MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 207743 | AB (A-rated, therapeutically equivalent) | September 19, 2017 | 100MG, 200MG, 300MG |
| APPCO PHARMA LLC | 209603 | AB (A-rated, therapeutically equivalent) | June 20, 2018 | 100MG, 200MG, 300MG, 400MG |
| ADAPTIS PHARMA PRIVATE LTD | 207863 | AB (A-rated, therapeutically equivalent) | February 4, 2019 | 100MG, 200MG, 300MG |
| CADILA PHARMACEUTICALS LTD | 211325 | AB (A-rated, therapeutically equivalent) | May 13, 2019 | 100MG, 200MG, 300MG |
| EPIC PHARMA LLC | 212990 | AB (A-rated, therapeutically equivalent) | September 30, 2020 | 100MG, 200MG, 300MG |
| RUBICON RESEARCH LTD | 211953 | AB (A-rated, therapeutically equivalent) | August 18, 2021 | 100MG, 200MG, 300MG |
| CAPLIN STERILES LTD | 214533 | AP (A-rated, therapeutically equivalent) | September 7, 2021 | 5MG/ML |
| UNICHEM LABORATORIES LTD | 212719 | AB (A-rated, therapeutically equivalent) | August 8, 2022 | 100MG, 200MG, 300MG |
| MACLEODS PHARMACEUTICALS LTD | 217949 | AB (A-rated, therapeutically equivalent) | September 23, 2025 | 100MG, 200MG, 300MG |
| AMNEAL EU LTD | 218870 | AP (A-rated, therapeutically equivalent) | October 2, 2025 | 5MG/ML |
Questions
Is there a generic for Normodyne?
Yes. The generic name for Normodyne is labetalol. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Normodyne?
The active ingredient in Normodyne is labetalol, 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.