FDA Orange Book
Generic for Exelon
Exelon contains rivastigmine. 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 Exelon is rivastigmine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Exelon products the Orange Book lists.
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Exelon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 1.5MG BASE | Discontinued | None | 8 | AB |
| capsule, oral | EQ 3MG BASE | Discontinued | None | 8 | AB |
| capsule, oral | EQ 4.5MG BASE | Discontinued | None | 8 | AB |
| capsule, oral | EQ 6MG BASE | Discontinued | None | 8 | AB |
| film, extended release, transdermal | 13.3MG/24HR | Marketed (Rx) | AB | 5 | AB |
| film, extended release, transdermal | 4.6MG/24HR | Marketed (Rx) | AB | 5 | AB |
| film, extended release, transdermal | 9.5MG/24HR | Marketed (Rx) | AB | 5 | AB |
| solution, oral | EQ 2MG BASE/ML | Discontinued | None | 0 | None |
NDA 020823, 022083, 021025, 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 rivastigmine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES INC | 077130 | AB (A-rated, therapeutically equivalent) | October 31, 2007 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| WATSON LABORATORIES INC | 077129 | AB (A-rated, therapeutically equivalent) | January 8, 2008 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 091689 | AB (A-rated, therapeutically equivalent) | June 12, 2012 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 203148 | AB (A-rated, therapeutically equivalent) | August 22, 2014 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| ORBION PHARMACEUTICALS PRIVATE LTD | 090879 | AB (A-rated, therapeutically equivalent) | June 10, 2015 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| AUROBINDO PHARMA LTD | 204572 | AB (A-rated, therapeutically equivalent) | March 25, 2016 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| CADILA PHARMACEUTICALS LTD | 203844 | AB (A-rated, therapeutically equivalent) | February 13, 2017 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| CHARTWELL RX SCIENCES LLC | 207797 | AB (A-rated, therapeutically equivalent) | September 28, 2017 | EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE |
| MYLAN TECHNOLOGIES INC | 205622 | AB (A-rated, therapeutically equivalent) | June 20, 2018 | 13.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 207308 | AB (A-rated, therapeutically equivalent) | January 8, 2019 | 13.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR |
| ZYDUS PHARMACEUTICALS USA INC | 206318 | AB (A-rated, therapeutically equivalent) | March 4, 2019 | 13.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR |
| BRECKENRIDGE PHARMACEUTICAL INC | 209063 | AB (A-rated, therapeutically equivalent) | November 26, 2019 | 13.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 215445 | AB (A-rated, therapeutically equivalent) | September 23, 2025 | 13.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR |
Exelon NDC codes
Questions
Is there a generic for Exelon?
Yes. The generic name for Exelon is rivastigmine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Exelon products the Orange Book lists.
What is the generic name for Exelon?
The active ingredient in Exelon is rivastigmine, 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 Exelon and Rivastigmine
- What is Exelon used for?FDA label uses
- Is Exelon a controlled substance?Federal schedule
- What is Rivastigmine used for?FDA label uses
- Is Rivastigmine a controlled substance?Federal schedule
- Cholinesterase Inhibitors listFDA drug class
- NDC 0078-0501Exelon NDC record
- NDC 0078-0502Exelon NDC record
- NDC 0078-0503Exelon NDC record