FDA Orange Book
Generic for Vasotec
Vasotec contains enalapril. 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 Vasotec is enalapril. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Vasotec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1.25MG/ML | Discontinued | None | 3 | AP |
| tablet, oral | 10MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 7 | AB |
NDA 019309, 018998, held by BIOVAIL LABORATORIES INTERNATIONAL SRL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic enalapril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL INJECTABLES LLC | 075634 | AP (A-rated, therapeutically equivalent) | August 22, 2000 | 1.25MG/ML |
| DR REDDYS LABORATORIES LTD | 075578 | AP (A-rated, therapeutically equivalent) | August 22, 2000 | 1.25MG/ML |
| HERITAGE PHARMA LABS INC | 075479 | AB (A-rated, therapeutically equivalent) | August 22, 2000 | 10MG, 2.5MG, 20MG, 5MG |
| PHARMAZONE | 075483 | AB (A-rated, therapeutically equivalent) | August 22, 2000 | 10MG, 2.5MG, 20MG, 5MG |
| SANDOZ INC | 075459 | AB (A-rated, therapeutically equivalent) | August 22, 2000 | 10MG, 20MG |
| SANDOZ INC | 075496 | AB (A-rated, therapeutically equivalent) | August 22, 2000 | 2.5MG, 5MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075657 | AB (A-rated, therapeutically equivalent) | January 23, 2001 | 10MG, 2.5MG, 20MG, 5MG |
| AIPING PHARMACEUTICAL INC | 075178 | AB (A-rated, therapeutically equivalent) | March 23, 2001 | 10MG, 2.5MG, 20MG, 5MG |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078687 | AP (A-rated, therapeutically equivalent) | December 23, 2008 | 1.25MG/ML |
| PRINSTON PHARMACEUTICAL INC | 213273 | AB (A-rated, therapeutically equivalent) | July 7, 2022 | 10MG, 2.5MG, 20MG, 5MG |
| UNIQUE PHARMACEUTICAL LABORATORIES | 218531 | AB (A-rated, therapeutically equivalent) | September 19, 2024 | 10MG, 2.5MG, 20MG, 5MG |
Vasotec NDC codes
Questions
Is there a generic for Vasotec?
Yes. The generic name for Vasotec is enalapril. 10 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 Vasotec?
The active ingredient in Vasotec is enalapril, 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.