Orphenadrine
Disipal, Orphenadrine, Orphengesic (orphenadrine) is a small molecule pharmaceutical. Orphenadrine was first approved as Norflex on 1982-01-01. It is used to treat muscle cramp, muscle rigidity, myositis, pain, and spasm amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Orphenadrine (discontinued: Disipal, Norflex, Orphenadrine)
CombinationsOrphengesic (discontinued: Invagesic, Norgesic, Orphenadrine citrate, aspirin, caffeine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Orphenadrine hydrochloride
Orphenadrine citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NORFLEX | Bausch Health Companies | N-012157 DISCN | 1982-01-01 | 1 products, RLD |
| NORFLEX | PAI Pharma | N-013055 DISCN | 1982-01-01 | 1 products, RLD |
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Aspirin
+
Caffeine
+
Orphenadrine citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NORGESIC | Bausch Health Companies | N-013416 DISCN | 1982-10-27 | 1 products, RLD |
| NORGESIC FORTE | Bausch Health Companies | N-013416 DISCN | 1982-10-27 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| norflex | ANDA | 2020-12-04 |
| norgesic | ANDA | 2024-01-08 |
| norgesic forte | ANDA | 2024-01-27 |
| orphenadrine citrate | ANDA | 2025-09-10 |
| orphenadrine citrate aspirin caffeine | ANDA | 2024-07-25 |
| orphenadrine citrate exended-release | 2008-04-09 | |
| orphenadrine citrate, aspirin and caffeine | ANDA | 2025-01-13 |
| orphengesic forte | ANDA | 2024-12-18 |
Indications
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Agency Specific
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EMA
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Patent Expiration
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ATC Codes
M: Musculo-skeletal system drugs
— M03: Muscle relaxants
— M03B: Muscle relaxants, centrally acting agents
— M03BC: Ethers chemically close to antihistamines, centrally acting muscle relaxants
— M03BC01: Orphenadrine (citrate)
— M03BC51: Orphenadrine, combinations
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04A: Anticholinergic agents
— N04AB: Ethers chemically close to antihistamines, anticholinergic
— N04AB02: Orphenadrine (chloride)
HCPCS
Code | Description |
|---|---|
| J2360 | Injection, orphenadrine citrate, up to 60 mg |
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 3 | 1 | 4 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 2 | 1 | 3 |
| Pain management | D059408 | — | — | — | — | — | 1 | 1 | 2 |
| Low back pain | D017116 | — | M54.5 | — | — | 1 | 1 | — | 2 |
| Neoplasms | D009369 | — | C80 | — | — | — | 1 | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | — | — | — | 1 | — | 1 |
| Rectal neoplasms | D012004 | — | — | — | — | — | 1 | — | 1 |
| Constipation | D003248 | — | K59.0 | — | — | — | 1 | — | 1 |
| Diverticulitis | D004238 | EFO_1001460 | K57 | — | — | — | 1 | — | 1 |
| Colonic diverticulosis | D043963 | — | K57.30 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | — | 1 | 2 |
| Muscle cramp | D009120 | — | — | — | — | 1 | — | 1 | 2 |
| Spasm | D013035 | — | M62.83 | — | — | 1 | — | 1 | 2 |
| Back pain | D001416 | — | M54 | — | — | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Orphenadrine |
| INN | orphenadrine |
| Description | Orphenadrine is a tertiary amino compound which is the phenyl-o-tolylmethyl ether of 2-(dimethylamino)ethanol. It has a role as a NMDA receptor antagonist, a H1-receptor antagonist, an antiparkinson drug, a parasympatholytic, a muscle relaxant, a muscarinic antagonist and an antidyskinesia agent. It is a tertiary amino compound and an ether. |
| Classification | Small molecule |
| Drug class | sympathomimetics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ccccc1C(OCCN(C)C)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 83-98-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL900 |
| ChEBI ID | 7789 |
| PubChem CID | 4601 |
| DrugBank | DB01173 |
| UNII ID | AL805O9OG9 (ChemIDplus, GSRS) |
Target
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Orphenadrine
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Additional graphs summarizing 1,299 documents
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Safety
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Adverse Events
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936 adverse events reported
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