FDA Orange Book
Generic for Protopic
Protopic contains tacrolimus. 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 Protopic is tacrolimus. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Protopic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, topical | 0.03% | Marketed (Rx) | AB | 3 | AB |
| ointment, topical | 0.1% | Marketed (Rx) | AB | 4 | AB, BX |
NDA 050777, held by LEO PHARMA AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tacrolimus
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 200744 | AB (A-rated, therapeutically equivalent) | September 9, 2014 | 0.03%, 0.1% |
| ACCORD HEALTHCARE INC | 211688 | AB (A-rated, therapeutically equivalent) | January 31, 2019 | 0.03%, 0.1% |
| GLENMARK PHARMACEUTICALS LTD | 210393 | AB (A-rated, therapeutically equivalent) | August 16, 2023 | 0.03%, 0.1% |
| ENCUBE ETHICALS PRIVATE LTD | 212387 | BX (B-rated, not considered equivalent) | October 10, 2023 | 0.1% |
Protopic NDC codes
Questions
Is there a generic for Protopic?
Yes. The generic name for Protopic is tacrolimus. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Protopic?
The active ingredient in Protopic is tacrolimus, 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.