FDA Orange Book
Generic for Periactin
Periactin contains cyproheptadine. 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 Periactin is cyproheptadine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Periactin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 2MG/5ML | Discontinued | None | 4 | AA |
| tablet, oral | 4MG | Discontinued | None | 10 | AA |
NDA 013220, 012649, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cyproheptadine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 088212 | AA (A-rated, therapeutically equivalent) | May 26, 1983 | 4MG |
| MOUNTAIN LLC | 040537 | AA (A-rated, therapeutically equivalent) | September 30, 2003 | 4MG |
| KENTON CHEMICALS AND PHARMACEUTICALS CORP | 040644 | AA (A-rated, therapeutically equivalent) | May 30, 2006 | 4MG |
| RISING PHARMA HOLDINGS INC | 040668 | AA (A-rated, therapeutically equivalent) | June 28, 2006 | 2MG/5ML |
| INGENUS PHARMACEUTICALS LLC | 205087 | AA (A-rated, therapeutically equivalent) | September 23, 2015 | 4MG |
| TP ANDA HOLDINGS LLC | 206553 | AA (A-rated, therapeutically equivalent) | November 29, 2016 | 4MG |
| RISING PHARMA HOLDINGS INC | 207555 | AA (A-rated, therapeutically equivalent) | January 31, 2017 | 4MG |
| ZYDUS PHARMACEUTICALS USA INC | 208938 | AA (A-rated, therapeutically equivalent) | May 19, 2017 | 4MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 203191 | AA (A-rated, therapeutically equivalent) | July 13, 2017 | 2MG/5ML |
| STRIDES PHARMA INTERNATIONAL AG | 209172 | AA (A-rated, therapeutically equivalent) | April 11, 2018 | 4MG |
| PHARMAZONE | 209108 | AA (A-rated, therapeutically equivalent) | October 16, 2018 | 2MG/5ML |
| REGCON HOLDINGS LLC | 206676 | AA (A-rated, therapeutically equivalent) | April 12, 2019 | 4MG |
| QUAGEN PHARMACEUTICALS LLC | 212423 | AA (A-rated, therapeutically equivalent) | May 22, 2019 | 2MG/5ML |
| QUAGEN PHARMACEUTICALS LLC | 212491 | AA (A-rated, therapeutically equivalent) | February 24, 2021 | 4MG |
Questions
Is there a generic for Periactin?
Yes. The generic name for Periactin is cyproheptadine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Periactin?
The active ingredient in Periactin is cyproheptadine, 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.