FDA Orange Book
Generic for Librium
Librium contains chlordiazepoxide. 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 Librium is chlordiazepoxide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Librium products the Orange Book lists.
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Librium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 3 | AB |
| capsule, oral | 25MG | Discontinued | None | 3 | AB |
| capsule, oral | 5MG | Discontinued | None | 3 | AB |
| injectable, injection | 100MG/AMP | Discontinued | None | 0 | None |
NDA 012249, 012301, held by VALEANT PHARMACEUTICALS INTERNATIONAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic chlordiazepoxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 083116 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| CHARTWELL RX SCIENCES LLC | 084041 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| BAUSCH HEALTH US LLC | 085472 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| BARR LABORATORIES INC | 084769 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| CHARTWELL RX SCIENCES LLC | 084679 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| BAUSCH HEALTH US LLC | 085475 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| BARR LABORATORIES INC | 084768 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
| CHARTWELL RX SCIENCES LLC | 084678 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
| BAUSCH HEALTH US LLC | 085461 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
Questions
Is there a generic for Librium?
Yes. The generic name for Librium is chlordiazepoxide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Librium products the Orange Book lists.
What is the generic name for Librium?
The active ingredient in Librium is chlordiazepoxide, 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.