FDA Orange Book
Generic for Klonopin
Klonopin 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 is clonazepam. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Klonopin products the Orange Book lists.
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Klonopin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.125MG | Discontinued | None | 0 | None |
| tablet, oral | 0.25MG | Discontinued | None | 1 | None |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 8 | AB |
NDA 017533, held by CHEPLAPHARM ARZNEIMITTEL GMBH. 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 074569 | AB (A-rated, therapeutically equivalent) | September 10, 1996 | 0.5MG, 1MG, 2MG |
| ACTAVIS ELIZABETH LLC | 074869 | AB (A-rated, therapeutically equivalent) | October 31, 1996 | 0.5MG, 1MG, 2MG |
| SANDOZ INC | 074979 | AB (A-rated, therapeutically equivalent) | August 29, 1997 | 0.5MG, 1MG, 2MG |
| CHARTWELL RX SCIENCES LLC | 074925 | AB (A-rated, therapeutically equivalent) | September 30, 1997 | 0.5MG, 1MG, 2MG |
| AUROBINDO PHARMA USA INC | 075150 | AB (A-rated, therapeutically equivalent) | October 5, 1998 | 0.5MG, 1MG, 2MG |
| ACCORD HEALTHCARE INC | 077147 | AB (A-rated, therapeutically equivalent) | May 2, 2005 | 0.5MG, 1MG, 2MG |
| PRINSTON PHARMACEUTICAL INC | 077856 | AB (A-rated, therapeutically equivalent) | June 28, 2006 | 0.5MG, 1MG, 2MG |
| RUBICON RESEARCH LTD | 075468 | None (No TE code listed) | June 12, 2026 | 0.25MG, 0.5MG, 1MG, 2MG |
Klonopin NDC codes
Questions
Is there a generic for Klonopin?
Yes. The generic name for Klonopin is clonazepam. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Klonopin products the Orange Book lists.
What is the generic name for Klonopin?
The active ingredient in Klonopin 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.
More on Klonopin and Clonazepam
- What is Klonopin used for?FDA label uses
- Is Klonopin a controlled substance?Schedule IV
- What is Clonazepam used for?FDA label uses
- Is Clonazepam a controlled substance?Schedule IV
- Generic for Klonopin Rapidly DisintegratingFDA Orange Book
- Benzodiazepines listFDA drug class
- NDC 61269-605Klonopin NDC record
- NDC 61269-610Klonopin NDC record
- NDC 61269-620Klonopin NDC record
- Schedule IV drugs listDEA schedule