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Drug ReportsPyridoxine
Pyridoxine
Berocca Pn, Bonjesta, Diclegis, Infuvite, M.v.c. 9+, M.v.i, M.v.i. Lyophilized, Mvc, Pyridoxine, Tpn, Vitaped (pyridoxine) is a small molecule pharmaceutical. Pyridoxine was first approved as Bendectin on 1982-01-01. It is used to treat seizures and vitamin b 6 deficiency in the USA.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Pyridoxine (discontinued: Hexa-betalin, Pyridoxine)
Combinations
Bonjesta, Diclegis, Doxylamine pyridoxine, Infuvite (discontinued: Bendectin, Berocca pn, Doxylamine pyridoxine, M.v.c. 9+, M.v.i., M.v.i. lyophilized, Mvc, Tpn, Vitaped)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin e
Tradename
Company
Number
Date
Products
BEROCCA PNRocheN-006071 DISCN1985-10-10
1 products
Hide discontinued
Alpha-tocopherol acetate
+
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin k
Tradename
Company
Number
Date
Products
INFUVITE ADULTSandozN-021163 RX2000-05-18
2 products, RLD, RS
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Tocopherol acetate
+
Vitamin a
+
Vitamin k
Tradename
Company
Number
Date
Products
INFUVITE PEDIATRICSandozN-021265 RX2001-02-21
1 products, RLD, RS
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)SandozN-021265 RX2004-01-29
1 products, RLD, RS
Doxylamine succinate
+
Pyridoxine hydrochloride
Tradename
Company
Number
Date
Products
BONJESTADuchesnayN-209661 RX2016-11-07
1 products, RLD, RS
DICLEGISDuchesnayN-021876 RX2013-04-08
1 products, RLD, RS
Show 1 discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.C. 9+3APP PharmaceuticalsN-018440 DISCN1985-08-08
1 products
M.V.I.-12 ADULTHospiraN-008809 DISCN1985-08-08
2 products
MVC PLUSAllerganN-018439 DISCN1985-08-08
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.I.-12 ADULTHospiraN-008809 DISCN2004-04-22
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Phytonadione
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.I. PEDIATRICHospiraN-018920 DISCN2000-09-21
1 products, RLD
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
+
Vitamin k
Tradename
Company
Number
Date
Products
M.V.I. ADULTHospiraN-021625 DISCN2004-01-30
1 products, RLD
M.V.I. ADULT (PHARMACY BULK PACKAGE)HospiraN-021643 DISCN2004-02-18
1 products, RLD
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pantothenic acid
+
Phytonadione
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Vitamin a palmitate
+
Vitamin e
Tradename
Company
Number
Date
Products
VITAPEDHospiraN-020176 DISCN1993-12-29
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin 5'-phosphate sodium
+
Thiamine
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.I.-12 LYOPHILIZEDTeligentN-018933 DISCN1985-08-08
1 products
Hide discontinued
Niacinamide
+
Pyridoxine hydrochloride
+
Tyrosine
Tradename
Company
Number
Date
Products
TPNInternational MineralsN-008378 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
adult infuvite multiple vitaminsNew Drug Application2019-05-14
alleviaunapproved drug other2025-02-27
animi-3unapproved drug other2013-02-06
animi-3 with vitamin dunapproved drug other2011-05-23
bal-care dhaunapproved drug other2012-05-01
bal-care dha essentialunapproved drug other2012-05-01
bonjestaNew Drug Application2025-02-25
bp vit 3unapproved drug other2025-02-13
c-nate dhaunapproved drug other2024-01-22
centratexunapproved drug other2024-01-31
Show 86 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
headache—D006261R51
sleep initiation and maintenance disorders—D007319F51.01
allergic rhinitis perennialEFO_1001417D012221J30.89
seizures—D012640G40.4
vitamin b 6 deficiency—D026681E53.1
hypercholesterolemia—D006937—
hypophosphatemiaHP_0002148D017674—
hypertriglyceridemiaEFO_0004211D015228—
peripheral vascular diseasesEFO_0003875D016491I73.9
dermatitis—D003872L30.9
Show 30 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Doxylamine Succinate / Pyridoxine Hydrochloride, Bonjesta, Duchesnay
90894892033-02-18DPU-1382
93754042033-02-18DPU-1382
95267032033-02-18DPU-1382
99371322033-02-18DPU-1382
ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11H: Other plain vitamin preparations in atc
— A11HA: Other plain vitamin preparations in atc
— A11HA02: Pyridoxine (vit b6)
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AM: Combinations of drugs for treatment of tuberculosis
— J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
Code
Description
J3415
Injection, pyridoxine hcl, 100 mg
Clinical
Clinical Trials
740 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337————1——1
NeoplasmsD009369—C80——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.911——57
HypertensionD006973EFO_0000537I1011——46
Type 1 diabetes mellitusD003922EFO_0001359E10—1——56
AnxietyD001007EFO_0005230F41.111——56
Autistic disorderD001321EFO_0003758F84.0—2——46
Autism spectrum disorderD000067877—F84.0—2——46
Brain injuriesD001930—S06.9—3——25
Chronic painD059350———1——45
LymphomaD008223—C85.934———4
Heart diseasesD006331EFO_0003777I51.9—2——24
Show 70 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825—G31.841———78
Bone fracturesD050723EFO_0003931T14.81———34
Hip fracturesD006620EFO_0003964S72.001———23
Allergic rhinitisD065631—J30.91———12
RhinitisD012220EFO_0008521J311———12
Biological availabilityD001682——1———12
BurnsD002056—T30.01———12
Heart rateD006339EFO_0004326—1————1
Triple negative breast neoplasmsD064726——1————1
RecurrenceD012008——1————1
Show 11 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Body weightD001835EFO_0004338—————77
Growth disordersD006130——————66
AggressionD000374EFO_0003015—————44
Parkinson diseaseD010300EFO_0002508G20————44
Premenstrual syndromeD011293—N94.3————44
Healthy dietD000072001——————44
Diet therapyD004035——————33
HeadacheD006261—R51————33
ConstipationD003248—K59.0————33
CognitionD003071EFO_0003925—————33
Show 202 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePyridoxine
INNpyridoxine
Description
Pyridoxine is a hydroxymethylpyridine with hydroxymethyl groups at positions 4 and 5, a hydroxy group at position 3 and a methyl group at position 2. The 4-methanol form of vitamin B6, it is converted intoto pyridoxal phosphate which is a coenzyme for synthesis of amino acids, neurotransmitters, sphingolipids and aminolevulinic acid. It has a role as a cofactor, a human metabolite, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite and a mouse metabolite. It is a monohydroxypyridine, a vitamin B6, a member of methylpyridines and a hydroxymethylpyridine.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc(CO)c(CO)c1O
Identifiers
PDB—
CAS-ID65-23-6
RxCUI—
ChEMBL IDCHEMBL1364
ChEBI ID16709
PubChem CID1054
DrugBankDB00165
UNII IDKV2JZ1BI6Z (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Pyridoxine
+
Doxylamine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Pyridoxine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 43,901 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal, Citranatal 90 dha, Citranatal assure, Citranatal dha, Citranatal essence, Citranatal harmony, Citranatal harmony 2.1, Citranatal harmony 3.0, Citranatal medley, Citranatal rx, Healthy mamabe well rounded, Marnatal f, Moms choice rx, Natafort, Nestabs, Nestabs dha, Nestabs one, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-dha, Pnv-omega, Pnv-select, Pr natal 400, Pr natal 400 ec, Pr natal 430, Pr natal 430 ec, Pre-tabs dha, Prenata, Prenatal plus multivitamin plus dha minicaps, Prenate am, Prenate dha, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Select ob, Select-ob plus dha, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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5,634 adverse events reported
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