FDA Orange Book
Generic for Plaquenil
Plaquenil contains hydroxychloroquine. 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 Plaquenil is hydroxychloroquine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Plaquenil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | AB | 13 | AB |
NDA 009768, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydroxychloroquine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 040081 | AB (A-rated, therapeutically equivalent) | September 30, 1994 | 200MG |
| SANDOZ INC | 040104 | AB (A-rated, therapeutically equivalent) | November 30, 1995 | 200MG |
| CREEKWOOD PHARMACEUTICALS LLC | 040150 | AB (A-rated, therapeutically equivalent) | January 27, 1996 | 200MG |
| AUROBINDO PHARMA USA INC | 040274 | AB (A-rated, therapeutically equivalent) | May 29, 1998 | 200MG |
| IPCA LABORATORIES LTD | 040766 | AB (A-rated, therapeutically equivalent) | June 14, 2007 | 200MG |
| ZYDUS PHARMACEUTICALS USA INC | 040657 | AB (A-rated, therapeutically equivalent) | September 21, 2007 | 200MG |
| APPCO PHARMA LLC | 210441 | AB (A-rated, therapeutically equivalent) | May 1, 2018 | 200MG |
| ALKALOIDA CHEMICAL CO ZRT | 201691 | AB (A-rated, therapeutically equivalent) | May 8, 2018 | 200MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 210577 | AB (A-rated, therapeutically equivalent) | May 15, 2018 | 200MG |
| CHARTWELL RX SCIENCES LLC | 210543 | AB (A-rated, therapeutically equivalent) | July 6, 2018 | 200MG |
| LAURUS LABS LTD | 210959 | AB (A-rated, therapeutically equivalent) | January 15, 2019 | 200MG |
| ACCORD HEALTHCARE INC | 213342 | AB (A-rated, therapeutically equivalent) | April 7, 2020 | 200MG |
| PHARMAZONE | 212902 | AB (A-rated, therapeutically equivalent) | May 14, 2020 | 200MG |
Plaquenil NDC codes
Questions
Is there a generic for Plaquenil?
Yes. The generic name for Plaquenil is hydroxychloroquine. 13 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 Plaquenil?
The active ingredient in Plaquenil is hydroxychloroquine, 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 Plaquenil and Hydroxychloroquine
- What is Hydroxychloroquine used for?FDA label uses
- Is Hydroxychloroquine a controlled substance?Federal schedule
- Generic for SovunaFDA Orange Book
- Antimalarials listFDA drug class
- Antirheumatic Agents listFDA drug class
- NDC 59212-562Plaquenil NDC record
- NDC 71205-448Plaquenil NDC record
- NDC 71610-473Plaquenil NDC record