FDA Orange Book
Generic for Librax
Librax contains chlordiazepoxide and clidinium bromide. 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 Librax is chlordiazepoxide and clidinium bromide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Librax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 5MG;2.5MG | Marketed (Rx) | AB | 11 | AB |
NDA 012750, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic chlordiazepoxide and clidinium bromide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NUVO PHAMACEUTICALS INC | 211421 | AB (A-rated, therapeutically equivalent) | July 7, 2020 | 5MG;2.5MG |
| MISEMER PHARMACEUTICALS INC | 210579 | AB (A-rated, therapeutically equivalent) | July 29, 2020 | 5MG;2.5MG |
| CHARTWELL RX SCIENCES LLC | 213530 | AB (A-rated, therapeutically equivalent) | October 20, 2020 | 5MG;2.5MG |
| ALKEM LABORATORIES LTD | 214065 | AB (A-rated, therapeutically equivalent) | April 26, 2021 | 5MG;2.5MG |
| DR REDDYS LABORATORIES LTD | 214698 | AB (A-rated, therapeutically equivalent) | May 10, 2021 | 5MG;2.5MG |
| AMNEAL EU LTD | 215555 | AB (A-rated, therapeutically equivalent) | October 25, 2021 | 5MG;2.5MG |
| MICRO LABS LTD | 215835 | AB (A-rated, therapeutically equivalent) | July 19, 2022 | 5MG;2.5MG |
| MACLEODS PHARMACEUTICALS LTD | 215453 | AB (A-rated, therapeutically equivalent) | July 29, 2022 | 5MG;2.5MG |
| AUROBINDO PHARMA LTD | 216419 | AB (A-rated, therapeutically equivalent) | September 14, 2023 | 5MG;2.5MG |
| ALEMBIC PHARMACEUTICALS LTD | 216969 | AB (A-rated, therapeutically equivalent) | September 15, 2023 | 5MG;2.5MG |
| WINDER LABORATOIRIES LLC | 212344 | AB (A-rated, therapeutically equivalent) | July 8, 2024 | 5MG;2.5MG |
Librax NDC codes
Questions
Is there a generic for Librax?
Yes. The generic name for Librax is chlordiazepoxide and clidinium bromide. 11 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 Librax?
The active ingredient in Librax is chlordiazepoxide and clidinium bromide, 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.