FDA Orange Book
Generic for Aktipak
Aktipak contains erythromycin and benzoyl peroxide. 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 Aktipak is erythromycin and benzoyl peroxide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Aktipak products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 5%;3% | Discontinued | None | 1 | AB |
NDA 050769, held by BIOFRONTERA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic erythromycin and benzoyl peroxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 065385 | AB (A-rated, therapeutically equivalent) | September 18, 2015 | 5%;3% |
Questions
Is there a generic for Aktipak?
Yes. The generic name for Aktipak is erythromycin and benzoyl peroxide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Aktipak?
The active ingredient in Aktipak is erythromycin and benzoyl peroxide, 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.