FDA Orange Book
Generic for Norvasc
Norvasc contains amlodipine. 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 Norvasc is amlodipine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Norvasc products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 19 | AB |
| tablet, oral | EQ 2.5MG BASE | Marketed (Rx) | AB | 19 | AB |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | AB | 19 | AB |
NDA 019787, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amlodipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MACLEODS PHARMACEUTICALS LTD | 076719 | AB (A-rated, therapeutically equivalent) | May 23, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| TEVA PHARMACEUTICALS USA INC | 076846 | AB (A-rated, therapeutically equivalent) | June 28, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 078226 | AB (A-rated, therapeutically equivalent) | July 9, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| LUPIN LTD | 078043 | AB (A-rated, therapeutically equivalent) | July 12, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 078021 | AB (A-rated, therapeutically equivalent) | July 17, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| CHARTWELL RX SCIENCES LLC | 076692 | AB (A-rated, therapeutically equivalent) | July 20, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| INVAGEN PHARMACEUTICALS INC | 077955 | AB (A-rated, therapeutically equivalent) | August 28, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| CIPLA LTD | 077073 | AB (A-rated, therapeutically equivalent) | September 26, 2007 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| EPIC PHARMA LLC | 078552 | AB (A-rated, therapeutically equivalent) | April 8, 2009 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| ALKEM LABORATORIES LTD | 078925 | AB (A-rated, therapeutically equivalent) | May 4, 2009 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| ORBION PHARMACEUTICALS PRIVATE LTD | 078453 | AB (A-rated, therapeutically equivalent) | July 2, 2009 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| OXFORD PHARMACEUTICALS LLC | 078414 | AB (A-rated, therapeutically equivalent) | April 7, 2010 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| CHINA RESOURCES SAIKE PHARMACEUTICAL CO LTD | 090752 | AB (A-rated, therapeutically equivalent) | April 15, 2011 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| GRAVITI PHARMACEUTICALS INC | 201380 | AB (A-rated, therapeutically equivalent) | April 13, 2012 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| ACCORD HEALTHCARE INC | 202553 | AB (A-rated, therapeutically equivalent) | April 29, 2013 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| UNICHEM LABORATORIES LTD | 203245 | AB (A-rated, therapeutically equivalent) | October 21, 2013 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| INVAGEN PHARMACEUTICALS INC | 206367 | AB (A-rated, therapeutically equivalent) | December 10, 2015 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 207821 | AB (A-rated, therapeutically equivalent) | July 11, 2016 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| IPCA LABORATORIES LTD | 210489 | AB (A-rated, therapeutically equivalent) | September 22, 2026 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
Norvasc NDC codes
Questions
Is there a generic for Norvasc?
Yes. The generic name for Norvasc is amlodipine. 18 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 Norvasc?
The active ingredient in Norvasc is amlodipine, 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 Norvasc and Amlodipine
- What is Norvasc used for?FDA label uses
- Is Norvasc a controlled substance?Federal schedule
- What is Amlodipine used for?FDA label uses
- Is Amlodipine a controlled substance?Federal schedule
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- Norvasc Medicare Part D coverageBy plan and state
- NDC 0069-1520Norvasc NDC record
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