Chlordiazepoxide
/ Chlordiazepoxide, Chlordiazepoxide, Chlordiazepoxide /, Librax, Librelease, Libritabs, Librium, Menrium (chlordiazepoxide) is a small molecule pharmaceutical. Chlordiazepoxide was first approved as Limbitrol on 1982-01-01. It is used to treat alcohol withdrawal delirium and anxiety disorders in the USA. It is known to target thyrotropin-releasing hormone receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Chlordiazepoxide, Librium (discontinued: A-poxide, Chlordiazepoxide, Librelease, Libritabs, Librium, Lygen)
CombinationsChlordiazepoxide amitriptyline, Chlordiazepoxide clidinium, Librax (discontinued: Chlordiazepoxide amitriptyline, Chlordiazepoxide clidinium, Limbitrol, Menrium)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Chlordiazepoxide
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Estrogens
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esterified
Chlordiazepoxide hydrochloride
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Clidinium bromide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIBRAX | Bausch Health Companies | N-012750 RX | 1982-01-01 | 1 products, RLD, RS |
Chlordiazepoxide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIBRELEASE | Bausch Health Companies | N-017813 DISCN | 1983-09-12 | 1 products |
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Chlordiazepoxide hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIBRIUM | Bausch Health Companies | N-012301 DISCN | 1982-01-01 | 1 products |
| LIBRIUM | Bausch Health Companies | N-012249 DISCN | 1982-01-01 | 3 products, RLD |
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Amitriptyline hydrochloride
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Chlordiazepoxide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIMBITROL | Chartwell Pharmaceuticals | N-016949 DISCN | 1982-01-01 | 1 products, RLD |
| LIMBITROL DS | Chartwell Pharmaceuticals | N-016949 DISCN | 1982-01-01 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| chlordiazepoxide | ANDA | 2019-04-04 |
| chlordiazepoxide & amitriptyline hydrochloride | 2007-02-12 | |
| chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2025-03-15 |
| chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2024-11-20 |
| chlordiazepoxide hcl and clidinium bromide | ANDA | 2025-02-13 |
| chlordiazepoxide hydrochloride | ANDA | 2025-02-26 |
| chlordiazepoxide hydrochloride and clidinium bromide | ANDA | 2024-12-10 |
| chlordiazepoxide hydrochloride/clidinium bromide | unapproved drug other | 2019-04-01 |
| librax | New Drug Application | 2023-01-13 |
| not applicable | ANDA | 2021-12-27 |
Indications
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EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1990 | Injection, chlordiazepoxide hcl, up to 100 mg |
Clinical
Clinical Trials
7 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | — | 1 | 1 | 2 | 4 |
| Alcohol withdrawal delirium | D000430 | EFO_1000800 | — | — | — | 1 | 1 | 1 | 3 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 1 | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | 1 | 1 | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | 1 | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | 1 | — | — | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chest pain | D002637 | — | R07.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Chlordiazepoxide |
| INN | chlordiazepoxide |
| Description | 7-chloro-4-hydroxy-N-methyl-5-phenyl-3H-1,4-benzodiazepin-2-imine is a benzodiazepine. |
| Classification | Small molecule |
| Drug class | Benzodiazepine |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1 |
Identifiers
| PDB | — |
| CAS-ID | 58-25-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL451 |
| ChEBI ID | 3611 |
| PubChem CID | 2712 |
| DrugBank | DB00475 |
| UNII ID | 6RZ6XEZ3CR (ChemIDplus, GSRS) |
Target
Variants
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Financial
Revenue by drug
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Estimated US medical usage
Chlordiazepoxide
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Amitriptyline
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Chlordiazepoxide
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Chlordiazepoxide
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Clidinium
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Trends
PubMed Central
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Additional graphs summarizing 6,315 documents
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Safety
Black-box Warning
Black-box warning for: Chlordiazepoxide & amitriptyline hydrochloride, Chlordiazepoxide and amitriptyline hydrochloride, Chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride, Chlordiazepoxide hcl and clidinium bromide, Chlordiazepoxide hydrochloride, Chlordiazepoxide hydrochloride and clidinium bromide, Chlordiazepoxide hydrochloride/clidinium bromide, Librax, Not applicable
Adverse Events
Top Adverse Reactions
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1,787 adverse events reported
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