Promethazine hydrochloride and dextromethorphan hydrobromide, Nuedexta(dextromethorphan)

Auvelity, Bromanate, Bromfed-dm, Dimetane-dx, Mucinex, Nuedexta, Pherazine (dextromethorphan) is a small molecule pharmaceutical. Dextromethorphan was first approved as Promethazine hydrochloride and dextromethorphan hydrobromide on 1984-04-02. It is used to treat cough in the USA. It has been approved in Europe to treat neurobehavioral manifestations. It is known to target sigma non-opioid intracellular receptor 1 and glutamate receptor ionotropic, NMDA 2C.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
nervous system diseases	D009422
signs and symptoms pathological conditions	D013568
behavior and behavior mechanisms	D001520

Trade Name

FDA

EMA

Combinations

Auvelity, Mucinex, Nuedexta (generic drugs available since 1985-01-04, discontinued: Bromanate, Bromfed-dm, Dimetane-dx, Pherazine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Brompheniramine maleate

Dextromethorphan hydrobromide

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
DIMETANE-DX	A.H. Robins Company	N-019279 DISCN	1984-08-24	1 products, RLD

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Bupropion hydrochloride

Dextromethorphan hydrobromide

Tradename	Company	Number	Date	Products
AUVELITY	Axsome Malta	N-215430 RX	2022-08-18	1 products, RLD, RS

Dextromethorphan hydrobromide

Guaifenesin

Tradename	Company	Number	Date	Products
MUCINEX DM	RB Health	N-021620 OTC	2004-04-29	2 products, RLD

Dextromethorphan hydrobromide

Promethazine hydrochloride

Tradename	Company	Number	Date	Products
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	ANI PHARMS	N-011265 DISCN	1984-04-02	1 products, RLD

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Dextromethorphan hydrobromide

Quinidine sulfate

Tradename	Company	Number	Date	Products
NUEDEXTA	Avanir Pharmaceuticals	N-021879 RX	2010-10-29	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
auvelity	New Drug Application	2022-09-02
mucinex fast-max day cold and flu and night cold and flu	OTC monograph final	2023-06-15
nuedexta	New Drug Application	2022-11-30
severe cold and flu relief	OTC monograph final	2023-06-19

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cough	HP_0012735	D003371	R05

Agency Specific

FDA

EMA

Expiration	Code
BUPROPION HYDROCHLORIDE / DEXTROMETHORPHAN HYDROBROMIDE, AUVELITY, AXSOME
2025-08-18	NP

Patent Expiration

Patent	Expires	Flag	FDA Information
Bupropion Hydrochloride / Dextromethorphan Hydrobromide, Auvelity, Axsome
10780064	2040-01-07		U-3419
10925842	2040-01-07		U-3419
10940124	2040-01-07		U-3419
10966942	2040-01-07		U-3419
10780066	2034-11-09		U-3419
9168234	2034-11-05		U-3419
9198905	2034-11-05		U-3419
9205083	2034-11-05		U-3419
9238032	2034-11-05		U-3419
9278095	2034-11-05		U-3419
9314462	2034-11-05		U-3419
9370513	2034-11-05		U-3419
9375429	2034-11-05		U-3419
9408815	2034-11-05		U-3419
9421176	2034-11-05		U-3419
9457023	2034-11-05		U-3419
9457025	2034-11-05		U-3419
9474731	2034-11-05		U-3419
9486450	2034-11-05		U-3419
9700528	2034-11-05		U-3419
9700553	2034-11-05		U-3419
9707191	2034-11-05		U-3419
9763932	2034-11-05		U-3419
9861595	2034-11-05		U-3419
9867819	2034-11-05		U-3419
9968568	2034-11-05		U-3419
10058518	2034-11-05		U-3419
10064857	2034-11-05		U-3419
10080727	2034-11-05		U-3419
10092560	2034-11-05		U-3419
10092561	2034-11-05		U-3419
10105327	2034-11-05		U-3419
10105361	2034-11-05		U-3419
10251879	2034-11-05		U-3419
10463634	2034-11-05		U-3419
10512643	2034-11-05		U-3419
10548857	2034-11-05		U-3419
10596167	2034-11-05		U-3419
10772850	2034-11-05		U-3419
10786469	2034-11-05		U-3419
10786496	2034-11-05		U-3419
10799497	2034-11-05		U-3419
10806710	2034-11-05		U-3419
10864209	2034-11-05		U-3419
10874663	2034-11-05		U-3419
10874664	2034-11-05		U-3419
10874665	2034-11-05		U-3419
10881624	2034-11-05		U-3419
10881657	2034-11-05		U-3419
10894046	2034-11-05		U-3419
10894047	2034-11-05		U-3419
10898453	2034-11-05		U-3419
10933034	2034-11-05		U-3419
10945973	2034-11-05		U-3419
10966941	2034-11-05		U-3419
10966974	2034-11-05		U-3419
11020389	2034-11-05		U-3419
11058648	2034-11-05		U-3419
11090300	2034-11-05		U-3419
11096937	2034-11-05		U-3419
11123343	2034-11-05		U-3419
11129826	2034-11-05		U-3419
11141388	2034-11-05		U-3419
11141416	2034-11-05		U-3419
11147808	2034-11-05		U-3419
11185515	2034-11-05		U-3419
11191739	2034-11-05	DP	U-3419
11197839	2034-11-05	DP	U-3419
11207281	2034-11-05		U-3419
11213521	2034-11-05		U-3419
11229640	2034-11-05		U-3419
11234946	2034-11-05		U-3419
11253491	2034-11-05		U-3419
11253492	2034-11-05		U-3419
11273133	2034-11-05		U-3419
11273134	2034-11-05		U-3419
11285118	2034-11-05		U-3419
11285146	2034-11-05		U-3419
11291638	2034-11-05		U-3419
11291665	2034-11-05		U-3419
11298351	2034-11-05		U-3419
11298352	2034-11-05		U-3419
11311534	2034-11-05		U-3419
11344544	2034-11-05		U-3419
11357744	2034-11-05		U-3419
11364233	2034-11-05		U-3419
11382874	2034-11-05		U-3419
11419867	2034-11-05		U-3419
11426370	2034-11-05		U-3419
11426401	2034-11-05		U-3419
11433067	2034-11-05	DP	U-3419
11439636	2034-11-05		U-3419
11478468	2034-11-05		U-3419
11497721	2034-11-05		U-3419
11510918	2034-11-05		U-3419
11517542	2034-11-05		U-3419
11517543	2034-11-05		U-3419
11524007	2034-11-05		U-3419
11524008	2034-11-05		U-3419
11534414	2034-11-05	DP	U-3419
11541021	2034-11-05		U-3419
11541048	2034-11-05		U-3419
11596627	2034-11-05		U-3419
11617728	2034-11-05		U-3419
11617747	2034-11-05		U-3563
8569328	2033-10-29	DP	U-3419
Dextromethorphan Hydrobromide / Quinidine Sulfate, Nuedexta, Avanir Pharms
7659282	2026-08-13		U-1093
8227484	2023-07-17		U-1093

ATC Codes

N: Nervous system drugs

— N07: Other nervous system drugs in atc

— N07X: Other nervous system drugs in atc

— N07XX: Other nervous system drugs in atc

— N07XX59: Dextromethorphan, combinations

R: Respiratory system drugs

— R05: Cough and cold preparations

— R05D: Cough suppressants, excl. combinations with expectorants

— R05DA: Opium alkaloids and derivatives, cough suppressants

— R05DA09: Dextromethorphan

HCPCS

No data

Clinical

Clinical Trials

166 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			29	1	—	1	4	35
Cough	D003371	HP_0012735	R05	2	—	3	1	1	7
Major depressive disorder	D003865	EFO_0003761	F22	2	3	1	1	—	6
Alzheimer disease	D000544	EFO_0000249	F03	2	1	2	1	—	6
Respiratory tract infections	D012141		J06.9	1	1	3	2	—	6
Pseudobulbar palsy	D020828	EFO_1001131		—	—	1	3	—	4
Postoperative pain	D010149		G89.18	—	—	—	2	1	3
Common cold	D003139	EFO_0007214	J00	1	1	—	1	—	3
Stroke	D020521	EFO_0000712	I63.9	—	1	1	1	—	3
Bronchitis	D001991		J40	—	—	—	1	2	3

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369		C80	3	—	1	—	1	5
Treatment-resistant depressive disorder	D061218			1	3	1	—	—	4
Rett syndrome	D015518		F84.2	—	2	1	—	1	4
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	1	2	1	—	—	3
Schizophrenia	D012559	EFO_0000692	F20	2	2	1	—	—	3
Parkinson disease	D010300	EFO_0002508	G20	—	2	1	—	—	3
Pain	D010146	EFO_0003843	R52	—	1	1	—	1	3
Huntington disease	D006816		G10	1	—	1	—	—	2
Bipolar disorder	D001714	EFO_0000289	F30.9	—	—	2	—	—	2
Multiple sclerosis	D009103	EFO_0003885	G35	—	1	1	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neuralgia	D009437	EFO_0009430		—	5	—	—	—	5
Hyperalgesia	D006930			1	2	—	—	—	3
Fibromyalgia	D005356	EFO_0005687	M79.1	1	1	—	—	—	2
Spinal cord injuries	D013119	EFO_1001919		—	2	—	—	—	2
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	2	—	—	—	2
Smoking cessation	D016540	EFO_0004319		1	1	—	—	—	1
Migraine disorders	D008881	EFO_0003821	G43	—	1	—	—	—	1
Brain edema	D001929	EFO_1000845	G93.6	—	1	—	—	—	1
Dyskinesias	D020820		G24	—	1	—	—	—	1
Autistic disorder	D001321	EFO_0003758	F84.0	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug interactions	D004347			2	—	—	—	1	3
Food-drug interactions	D018565			2	—	—	—	—	2
Prostatic neoplasms	D011471		C61	2	—	—	—	—	2
Infections	D007239	EFO_0000544		1	—	—	—	1	2
Melanoma	D008545			1	—	—	—	—	1
Mitochondrial diseases	D028361	EFO_0000591		1	—	—	—	—	1
Therapeutic equivalency	D013810			1	—	—	—	—	1
Psoriasis	D011565	EFO_0000676	L40	1	—	—	—	—	1
Voice disorders	D014832			1	—	—	—	—	1
Mucociliary clearance	D009079			1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	—	—	—	—	1	1
Attention deficit disorder with hyperactivity	D001289	EFO_0003888	F90	—	—	—	—	1	1
Breast neoplasms	D001943	EFO_0003869	C50	—	—	—	—	1	1
Pituitary dwarfism	D004393	EFO_1001109	E23.0	—	—	—	—	1	1
Sleep apnea syndromes	D012891	EFO_0003877	G47.3	—	—	—	—	1	1
Neurotoxicity syndromes	D020258		G92	—	—	—	—	1	1
Fatigue	D005221	HP_0012378	R53.83	—	—	—	—	1	1
Pneumonia	D011014	EFO_0003106	J18	—	—	—	—	1	1
Lung diseases	D008171	EFO_0003818	J98.4	—	—	—	—	1	1
Pulmonary fibrosis	D011658		J84.10	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	DEXTROMETHORPHAN
INN	dextromethorphan
Description	Dextromethorphan is a 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene in which the sterocenters at positions 4a, 10 and 10a have S-configuration. It is a prodrug of dextrorphan and used as an antitussive drug for suppressing cough. It has a role as a NMDA receptor antagonist, a neurotoxin, a xenobiotic, an environmental contaminant, an antitussive, a prodrug and a oneirogen. It is functionally related to a dextrorphan. It is an enantiomer of a levomethorphan.
Classification	Small molecule
Drug class	deuterated compounds; narcotic antagonists/agonists (morphinan derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc2c(c1)[C@]13CCCC[C@@H]1[C@H](C2)N(C)CC3

Identifiers

PDB	—
CAS-ID	125-71-3
RxCUI	3289
ChEMBL ID	CHEMBL52440
ChEBI ID	—
PubChem CID	5360696
DrugBank	DB00514
UNII ID	7355X3ROTS (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

SIGMAR1

GRIN2C

Organism

Homo sapiens

Gene name

SIGMAR1

Gene synonyms

OPRS1, SRBP

NCBI Gene ID

10280

Protein name

sigma non-opioid intracellular receptor 1

Protein synonyms

Aging-associated gene 8 protein, hSigmaR1, SIG-1R, Sigma 1-type opioid receptor, Sigma1-receptor, Sigma1R, SR-BP, SR31747 binding protein 1, SR31747-binding protein

Uniprot ID

Q99720

Mouse ortholog

Sigmar1 (18391)

sigma non-opioid intracellular receptor 1 (O55242)

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 6,057 documents

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Safety

Black-box Warning

Black-box warning for: Auvelity

Adverse Events

Top Adverse Reactions

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97,043 adverse events reported

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