FDA Orange Book
Generic for Exforge HCT
Exforge HCT contains amlodipine, valsartan and hydrochlorothiazide. 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 Exforge HCT is amlodipine, valsartan and hydrochlorothiazide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Exforge HCT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE;12.5MG;160MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 10MG BASE;25MG;160MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 10MG BASE;25MG;320MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 5MG BASE;12.5MG;160MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 5MG BASE;25MG;160MG | Marketed (Rx) | AB | 3 | AB |
NDA 022314, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amlodipine, valsartan and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 201087 | AB (A-rated, therapeutically equivalent) | June 1, 2015 | EQ 10MG BASE;12.5MG;160MG, EQ 10MG BASE;25MG;160MG, EQ 10MG BASE;25MG;320MG, EQ 5MG BASE;12.5MG;160MG, EQ 5MG BASE;25MG;160MG |
| AUROBINDO PHARMA LTD | 206180 | AB (A-rated, therapeutically equivalent) | December 19, 2017 | EQ 10MG BASE;12.5MG;160MG, EQ 10MG BASE;25MG;160MG, EQ 10MG BASE;25MG;320MG, EQ 5MG BASE;12.5MG;160MG, EQ 5MG BASE;25MG;160MG |
| MACLEODS PHARMACEUTICALS LTD | 207299 | AB (A-rated, therapeutically equivalent) | January 7, 2025 | EQ 10MG BASE;12.5MG;160MG, EQ 10MG BASE;25MG;160MG, EQ 10MG BASE;25MG;320MG, EQ 5MG BASE;12.5MG;160MG, EQ 5MG BASE;25MG;160MG |
Exforge HCT NDC codes
Questions
Is there a generic for Exforge HCT?
Yes. The generic name for Exforge HCT is amlodipine, valsartan and hydrochlorothiazide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Exforge HCT?
The active ingredient in Exforge HCT is amlodipine, valsartan and hydrochlorothiazide, 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.