ascorbic acid Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4072 50-81-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vitamin c
  • L-Ascorbic acid
  • ascorbic acid
  • ascorbic acid (vit C)
  • sodium ascorbate
  • calcium ascorbate
  • ascorbic acid, monosodium salt
A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • Molecular weight: 176.12
  • Formula: C6H8O6
  • CLOGP: -1.76
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 107.22
  • ALOGS: 0.14
  • ROTB: 2

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P
0.25 g V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 0 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 333 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 567.77 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.35 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.05 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.26 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
None FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pneumonia aspiration 417.56 45.30 70 268 3672 2354075
Coma 355.78 45.30 70 268 8986 2348761
Gastrooesophageal reflux disease 355.48 45.30 70 268 9025 2348722
Somnolence 348.07 45.30 81 257 23404 2334343
Deafness transitory 135.72 45.30 18 320 165 2357582
Gastrointestinal pain 103.35 45.30 18 320 1088 2356659
Pharyngitis 90.71 45.30 18 320 2217 2355530
Hypophagia 85.78 45.30 19 319 3981 2353766
Ear infection 82.97 45.30 18 320 3423 2354324
Haemoglobin decreased 78.08 45.30 24 314 18127 2339620
Haematocrit decreased 73.52 45.30 17 321 4301 2353446
Contraindicated product administered 68.29 45.30 15 323 3006 2354741
Disability 67.34 45.30 12 326 820 2356927
Drug hypersensitivity 66.14 45.30 27 311 46616 2311131
Red blood cell sedimentation rate abnormal 65.86 45.30 11 327 512 2357235
Nausea 65.44 45.30 35 303 112154 2245593
Vomiting 64.28 45.30 30 308 71572 2286175
Weight decreased 59.99 45.30 22 316 28349 2329398
Decreased appetite 55.91 45.30 21 317 28870 2328877
Shoulder arthroplasty 54.60 45.30 9 329 385 2357362
Red blood cell count decreased 52.83 45.30 13 325 4253 2353494
Product compounding quality issue 49.00 45.30 6 332 26 2357721
Foot operation 48.78 45.30 9 329 744 2357003
C-reactive protein abnormal 48.25 45.30 9 329 790 2356957

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Coombs positive haemolytic anaemia 56.96 40.05 8 222 101 1746450
Chills 54.96 40.05 17 213 11670 1734881
Lymphadenitis 48.45 40.05 8 222 308 1746243
Completed suicide 45.50 40.05 16 214 16296 1730255
Ischaemic stroke 44.71 40.05 11 219 3211 1743340
Crystal nephropathy 42.90 40.05 6 224 73 1746478

Pharmacologic Action:

SourceCodeDescription
ATC A11GA01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS
Ascorbic acid (vitamin C), plain
ATC A11GB01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS
Ascorbic acid (vitamin C), combinations
ATC G01AD03 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Organic acids
ATC S01XA15 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
FDA CS M0001797 Ascorbic Acid
CHEBI has role CHEBI:21241 vitamin C
CHEBI has role CHEBI:64577 flour treatment agent
CHEBI has role CHEBI:77962 food antioxidant
MeSH PA D000975 Antioxidants
MeSH PA D018977 Micronutrients
MeSH PA D020011 Protective Agents
MeSH PA D014815 Vitamins

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ascorbic acid deficiency indication 76169001
Breastfeeding (mother) indication 413712001
Coronavirus infection off-label use 186747009
Anuria contraindication 2472002 DOID:2983
Hypocalcemia contraindication 5291005
Peptic ulcer contraindication 13200003 DOID:750
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Operation on stomach contraindication 16453004
Primary hyperoxaluria contraindication 17901006 DOID:2977
Hypocupremia contraindication 19577007
Hyperphosphatemia contraindication 20165001 DOID:0050459
Sunburn contraindication 23346002
Acute vomiting contraindication 23971007
Multiple sclerosis contraindication 24700007 DOID:2377
Gastroenteritis contraindication 25374005 DOID:2326
Acute tuberculosis contraindication 25629007
Hypervitaminosis D contraindication 27712000 DOID:9971
Complete atrioventricular block contraindication 27885002
Toxic megacolon contraindication 28536002 DOID:1770
Dental fluorosis contraindication 30265004
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Hemosiderosis contraindication 39011001 DOID:12119
Gastrointestinal ulcer contraindication 40845000
Toxic colitis contraindication 42359007
Hypokalemia contraindication 43339004
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Congenital myotonia, autosomal dominant form contraindication 57938005
Acute nephropathy contraindication 58574008
Leber's optic atrophy contraindication 58610003 DOID:705
Hemolytic anemia contraindication 61261009 DOID:583
Allergic rhinitis contraindication 61582004
Hypervitaminosis A contraindication 64559002 DOID:9972
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Rheumatoid arthritis contraindication 69896004 DOID:7148
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperchloremia contraindication 74450001
Third degree burn injury contraindication 80247002
Intestinal obstruction contraindication 81060008 DOID:8437
Atrophic gastritis contraindication 84568007 DOID:8929
Human immunodeficiency virus infection contraindication 86406008 DOID:526
Wilson's disease contraindication 88518009
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Leukemia, disease contraindication 93143009 DOID:1240
Kidney stone contraindication 95570007
Anemia due to enzyme deficiency contraindication 111577008
Gastrointestinal obstruction contraindication 126765001
Hb SS disease contraindication 127040003 DOID:10923
Seizure disorder contraindication 128613002
Osteolysis contraindication 203522001
Disease of liver contraindication 235856003 DOID:409
Hyporeninemic hypoaldosteronism contraindication 236464008
Esophageal dysmotility contraindication 266434009 DOID:9192
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Gastric retention contraindication 307227006
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
At risk for aspiration contraindication 371736008
Diverticular disease contraindication 397881000
Hemochromatosis contraindication 399187006 DOID:2352
Denuded skin contraindication 418242004
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006
Vitamin K Deficiency Induced Hypoprothrombinemia contraindication
Malabsorption States contraindication
Repeated Blood Transfusions contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.02 acidic
pKa2 9.62 acidic
pKa3 11.85 acidic
pKa4 12.53 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
7.54GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9592252 Aug. 11, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9326969 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
7.54GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL May 4, 2021 NEW PRODUCT
25,000MG/50ML (500MG/ML) ASCOR MCGUFF N209112 Oct. 2, 2017 RX SOLUTION INTRAVENOUS Oct. 2, 2024 FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Solute carrier family 23 member 1 Unclassified WOMBAT-PK
Solute carrier family 23 member 2 Transporter WOMBAT-PK
Procollagen-lysine,2-oxoglutarate 5-dioxygenase 1 Enzyme WOMBAT-PK
Prolyl 4-hydroxylase subunit alpha-1 Enzyme WOMBAT-PK
Tyrosinase Enzyme IC50 4.49 CHEMBL
Pancreatic alpha-amylase Unclassified IC50 4.58 CHEMBL

External reference:

IDSource
D001205 MESH_DESCRIPTOR_UI
4017646 VUID
N0000146025 NUI
C0003968 UMLSCUI
D00018 KEGG_DRUG
183E4W213W UNII
5743-28-2 SECONDARY_CAS_RN
46123006 SNOMEDCT_US
43706004 SNOMEDCT_US
4017471 VANDF
4017646 VANDF
001010 NDDF
6032 MMSL
1151 RXNORM
4221 MMSL
d00426 MMSL
1132 MMSL
5687 MMSL
54670067 PUBCHEM_CID
CHEBI:29073 CHEBI
CHEMBL196 ChEMBL_ID
DB00126 DRUGBANK_ID
CHEMBL591665 ChEMBL_ID
372 INN_ID
ASC PDB_CHEM_ID
C069207 MESH_SUPPLEMENTAL_RECORD_UI
CHEMBL2146095 ChEMBL_ID
4781 IUPHAR_LIGAND_ID
DB14482 DRUGBANK_ID
DB14483 DRUGBANK_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ferralet 90 HUMAN PRESCRIPTION DRUG LABEL 5 0178-0089 TABLET, FILM COATED 120 mg ORAL unapproved drug other 14 sections
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 120 mg ORAL Unapproved drug other 12 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 138 mg ORAL unapproved drug other 13 sections
CitraNatal Bloom DHA HUMAN PRESCRIPTION DRUG LABEL 6 0178-0816 KIT 120 mg ORAL unapproved drug other 10 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 13 0178-0821 TABLET 120 mg ORAL unapproved drug other 10 sections
CitraNatal 90 DHA HUMAN OTC DRUG LABEL 10 0178-0829 TABLET 120 mg ORAL Unapproved drug other 10 sections
CITRANATAL B-CALM HUMAN PRESCRIPTION DRUG LABEL 6 0178-0832 KIT 120 mg None unapproved drug other 11 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 11 0178-0858 TABLET 120 mg ORAL Unapproved drug other 11 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 12 0178-0859 TABLET 120 mg ORAL Unapproved drug other 8 sections
CitraNatal HUMAN PRESCRIPTION DRUG LABEL 7 0178-0866 KIT 120 mg None Unapproved drug other 11 sections
CitraNatal Assure HUMAN PRESCRIPTION DRUG LABEL 13 0178-0891 KIT 120 mg None unapproved drug other 12 sections
CitraNatal Assure HUMAN PRESCRIPTION DRUG LABEL 14 0178-0893 KIT 120 mg None Unapproved drug other 12 sections
CitraNatal DHA HUMAN PRESCRIPTION DRUG LABEL 14 0178-0894 KIT 120 mg None unapproved drug other 11 sections
CitraNatal DHA HUMAN OTC DRUG LABEL 12 0178-0898 TABLET 120 mg ORAL Unapproved drug other 10 sections
Antiflu Kids HUMAN OTC DRUG LABEL 3 0280-0046 POWDER, FOR SOLUTION 50 mg ORAL Export only 1 sections
Multi-Vit with Fluoride HUMAN PRESCRIPTION DRUG LABEL 10 0603-1449 SOLUTION 35 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Multi-Vit with Fluoride HUMAN PRESCRIPTION DRUG LABEL 10 0603-1450 SOLUTION 35 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Multi-Vit with Fluoride and Iron HUMAN PRESCRIPTION DRUG LABEL 10 0603-1452 SOLUTION 35 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Tri-Vit with Fluoride Drops HUMAN PRESCRIPTION DRUG LABEL 4 0603-1785 SOLUTION 35 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Tri-Vit with Fluoride Drops HUMAN PRESCRIPTION DRUG LABEL 4 0603-1786 SOLUTION 35 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Tri-Vit With Fluoride And Iron Drops HUMAN PRESCRIPTION DRUG LABEL 5 0603-1787 SOLUTION 35 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 11 0642-0070 CAPSULE, GELATIN COATED 30 mg ORAL unapproved drug other 6 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 9 0642-0072 CAPSULE 60 mg ORAL UNAPPROVED DRUG OTHER 9 sections
Select-OB Plus DHA HUMAN PRESCRIPTION DRUG LABEL 15 0642-0075 KIT 60 mg None Unapproved drug other 10 sections
Vitafol-OB Plus DHA HUMAN PRESCRIPTION DRUG LABEL 10 0642-0076 KIT 70 mg None Unapproved drug other 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 11 0642-0077 TABLET, CHEWABLE 60 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Vitafol OB HUMAN PRESCRIPTION DRUG LABEL 9 0642-0079 TABLET 70 mg ORAL Unapproved drug other 11 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 12 0642-0092 CAPSULE, LIQUID FILLED 12 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 16 0642-0093 CAPSULE, LIQUID FILLED 30 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 12 0642-0096 KIT 60 mg None UNAPPROVED DRUG OTHER 10 sections