FDA Orange Book
Generic for Klonopin Rapidly Disintegrating
Klonopin Rapidly Disintegrating contains clonazepam. 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 Klonopin Rapidly Disintegrating is clonazepam. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Klonopin Rapidly Disintegrating products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 0.125MG | Discontinued | None | 4 | AB |
| tablet, orally disintegrating, oral | 0.25MG | Discontinued | None | 4 | AB |
| tablet, orally disintegrating, oral | 0.5MG | Discontinued | None | 4 | AB |
| tablet, orally disintegrating, oral | 1MG | Discontinued | None | 4 | AB |
| tablet, orally disintegrating, oral | 2MG | Discontinued | None | 4 | AB |
NDA 020813, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clonazepam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 077171 | AB (A-rated, therapeutically equivalent) | August 3, 2005 | 0.125MG, 0.25MG, 0.5MG, 1MG, 2MG |
| BARR LABORATORIES INC | 077194 | AB (A-rated, therapeutically equivalent) | August 10, 2005 | 0.125MG, 0.25MG, 0.5MG, 1MG, 2MG |
| ALEMBIC PHARMACEUTICALS LTD | 211033 | AB (A-rated, therapeutically equivalent) | June 28, 2019 | 0.125MG, 0.25MG, 0.5MG, 1MG, 2MG |
| RUBICON RESEARCH LTD | 216988 | AB (A-rated, therapeutically equivalent) | May 21, 2026 | 0.125MG, 0.25MG, 0.5MG, 1MG, 2MG |
Questions
Is there a generic for Klonopin Rapidly Disintegrating?
Yes. The generic name for Klonopin Rapidly Disintegrating is clonazepam. 4 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 Klonopin Rapidly Disintegrating?
The active ingredient in Klonopin Rapidly Disintegrating is clonazepam, 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.