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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
adult infuvite multiple vitamins for infusion pharmacy bulkNew Drug Application2013-01-01
animi-3unapproved drug other2013-02-06
animi-3 with vitamin dunapproved drug other2011-05-23
bacminunapproved drug other2014-05-02
bal-care dhaunapproved drug other2012-05-01
bal-care dha essentialunapproved drug other2012-05-01
bonjestaNew Drug Application2023-07-07
bp vit 3unapproved drug other2023-10-11
c-nate dhaunapproved drug other2024-01-22
Show 103 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
713 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A193141851146
AnemiaD000740HP_0001903D64.9—3741730
Hiv infectionsD015658EFO_0000764B20121141028
SyndromeD013577——17321326
ObesityD009765EFO_0001073E66.911121519
MalnutritionD044342EFO_0008572E40-E46—2211418
Iron deficienciesD000090463———1221217
Diabetes mellitusD003920HP_0000819E08-E13—333716
Iron-deficiency anemiaD018798HP_0001891D50—1221116
NeoplasmsD009369—C804252315
Show 106 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———741—1426
Breast neoplasmsD001943EFO_0003869C50143—412
Pulmonary tuberculosisD014397EFO_1000049A15155—111
HivD006678——233—310
FatigueD005221HP_0012378R53.83—32—510
Acquired immunodeficiency syndromeD000163EFO_0000765B20——4—59
DiarrheaD003967HP_0002014R19.7——1—89
Colorectal neoplasmsD015179——133—38
Myocardial ischemiaD017202EFO_1001375I20-I25—32—16
Hand-foot syndromeD060831EFO_1001893———4—26
Show 110 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I1011——46
Type 1 diabetes mellitusD003922EFO_0001359E10—1——56
Autistic disorderD001321HP_0000717F84.0—2——46
Autism spectrum disorderD000067877HP_0000729F84.0—2——46
DepressionD003863—F33.911——46
AnxietyD001007EFO_0005230F41.111——45
Brain injuriesD001930—S06.9—3——25
Chronic painD059350HP_0012532——1——45
LymphomaD008223—C85.934———4
Heart diseasesD006331EFO_0003777I51.9—2——24
Show 69 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825HP_0001268G31.841———78
Bone fracturesD050723EFO_0003931T14.81———34
Hip fracturesD006620EFO_0003964S72.001———23
Biological availabilityD001682——1———12
Heart rateD006339EFO_0004326—1————1
Triple negative breast neoplasmsD064726——1————1
RecurrenceD012008——1————1
Myeloproliferative disordersD009196—D47.11————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
Myelodysplastic-myeloproliferative diseasesD054437——1————1
Show 9 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
Premenstrual syndromeD011293—N94.3————44
Healthy dietD000072001——————44
Diet therapyD004035——————33
CognitionD003071EFO_0003925—————33
HypercholesterolemiaD006937HP_0003124—————33
DwarfismD004392HP_0003510E34.31————33
MetabolismD008660GO_0008152—————33
Show 194 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
$
€
£
â‚£
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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Number of purchases
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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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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 40,993 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal, Citranatal 90 dha, Citranatal assure, Citranatal b-calm, 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, O-cal prenatal vitamin, 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, Prenaissance, Prenaissance plus, 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, Tricare prenatal, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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4,867 adverse events reported
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