FDA Orange Book
Generic for Daraprim
Daraprim contains pyrimethamine. 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 Daraprim is pyrimethamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Daraprim products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Marketed (Rx) | AB | 3 | AB |
NDA 008578, held by TILDE SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pyrimethamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMAZONE | 207127 | AB (A-rated, therapeutically equivalent) | February 28, 2020 | 25MG |
| TEVA PHARMACEUTICALS DEVELOPMENT INC | 215506 | AB (A-rated, therapeutically equivalent) | August 13, 2021 | 25MG |
| AUROBINDO PHARMA LTD | 216983 | AB (A-rated, therapeutically equivalent) | October 25, 2022 | 25MG |
Daraprim NDC codes
Questions
Is there a generic for Daraprim?
Yes. The generic name for Daraprim is pyrimethamine. 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 Daraprim?
The active ingredient in Daraprim is pyrimethamine, 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.