levomefolic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4621 31690-09-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • L-methylfolate calcium
  • levomefolate magnesium
  • methylfolate
  • levomefolic acid
  • levomefolate calcium
  • metafolin
an ingredient in Contraceptives, Oral, Combined
  • Molecular weight: 459.46
  • Formula: C20H25N7O6
  • CLOGP: -0.74
  • LIPINSKI: 2
  • HAC: 13
  • HDO: 7
  • TPSA: 198.48
  • ALOGS: -3.14
  • ROTB: 9

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 24, 2010 FDA BAYER HLTHCARE

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
Anxiety 28.50 19.36 35 2010 217506 63269471

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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
Anxiety 37.82 20.46 41 2266 248471 79493610

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA CS M0008658 Folic Acid
FDA EPC N0000178369 Folate Analog
CHEBI has role CHEBI:35469 antidepressants

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Contraception indication 13197004
Acne vulgaris indication 88616000
Polycystic ovaries off-label use 69878008
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Hypocalcemia contraindication 5291005
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Myocardial infarction contraindication 22298006 DOID:5844
Diplopia contraindication 24982008
Retinal hemorrhage contraindication 28998008
Depressive disorder contraindication 35489007
Chloasma contraindication 36209000
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Thrombosis of retinal vein contraindication 46085004
Humoral hypercalcemia of malignancy contraindication 47709007
Chronic heart failure contraindication 48447003
Dementia contraindication 52448006
Hepatic porphyria contraindication 55056006 DOID:3133
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Thrombophlebitis contraindication 64156001 DOID:3875
Intermenstrual bleeding - irregular contraindication 64996003
Diabetes mellitus contraindication 73211009 DOID:9351
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Uterine leiomyoma contraindication 95315005 DOID:13223
Deep venous thrombosis contraindication 128053003
Seizure disorder contraindication 128613002
Endometriosis contraindication 129103003
Bed-ridden contraindication 160685001
Mammography abnormal contraindication 168750009
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007
Pulmonary thromboembolism contraindication 233935004
Thrombophilia contraindication 234467004 DOID:2452
Disease of liver contraindication 235856003 DOID:409
Endometrial carcinoma contraindication 254878006 DOID:2871
Chorea contraindication 271700006
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Functional visual loss contraindication 313165001
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Cardiovascular event risk contraindication 395112001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Porphyria contraindication 418470004
Optic disc edema contraindication 423341008 DOID:146
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.61 acidic
pKa2 4.77 acidic
pKa3 11.04 acidic
pKa4 12.96 acidic
pKa5 5.7 Basic
pKa6 5.28 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG BEYAZ BAYER HLTHCARE N022532 Sept. 24, 2010 RX TABLET ORAL 11617751 July 17, 2030 PREVENTION OF PREGNANCY
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG BEYAZ BAYER HLTHCARE N022532 Sept. 24, 2010 RX TABLET ORAL 11617751 July 17, 2030 RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG BEYAZ BAYER HLTHCARE N022532 Sept. 24, 2010 RX TABLET ORAL 11617751 July 17, 2030 TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YEARS OF AGE IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG BEYAZ BAYER HLTHCARE N022532 Sept. 24, 2010 RX TABLET ORAL 11617751 July 17, 2030 TREATMENT OF MOOD CHANGES AND/OR ANXIETY AS SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG SAFYRAL BAYER HLTHCARE N022574 Dec. 16, 2010 RX TABLET ORAL 11617751 July 17, 2030 PREVENTION OF PREGNANCY
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG SAFYRAL BAYER HLTHCARE N022574 Dec. 16, 2010 RX TABLET ORAL 11617751 July 17, 2030 RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Thymidylate synthase Enzyme WOMBAT-PK

External reference:

IDSource
D09353 KEGG_DRUG
1429498-11-2 SECONDARY_CAS_RN
151533-22-1 SECONDARY_CAS_RN
4030850 VANDF
CHEBI:136009 CHEBI
CHEMBL1231574 ChEMBL_ID
CHEMBL1615371 ChEMBL_ID
C005984 MESH_SUPPLEMENTAL_RECORD_UI
C569381 MESH_SUPPLEMENTAL_RECORD_UI
8917 INN_ID
DB11256 DRUGBANK_ID
8S95DH25XC UNII
1025342 RXNORM
172826 MMSL
27556 MMSL
27740 MMSL
362111 MMSL
d07578 MMSL
007202 NDDF
015780 NDDF
432164001 SNOMEDCT_US
432165000 SNOMEDCT_US
449236003 SNOMEDCT_US
C2825462 UMLSCUI
C2F PDB_CHEM_ID
THH PDB_CHEM_ID
135398561 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0077 TABLET, CHEWABLE 0.60 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 1020 ug ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 1020 ug ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Nano HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 1020 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol Nano HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 1020 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0120 TABLET, CHEWABLE 0.60 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 1020 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 1020 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Quflora Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 13 15370-100 LIQUID 35 ug ORAL UNAPPROVED DRUG OTHER 11 sections
Quflora Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 13 15370-101 LIQUID 81 ug ORAL UNAPPROVED DRUG OTHER 11 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 14 15370-103 TABLET, CHEWABLE 108 ug ORAL UNAPPROVED DRUG OTHER 12 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 14 15370-104 TABLET, CHEWABLE 108 ug ORAL UNAPPROVED DRUG OTHER 12 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 14 15370-105 TABLET, CHEWABLE 108 ug ORAL UNAPPROVED DRUG OTHER 12 sections
TriStart DHA HUMAN PRESCRIPTION DRUG LABEL 15 15370-250 CAPSULE, LIQUID FILLED 600 ug ORAL UNAPPROVED DRUG OTHER 12 sections
Poly-ViFlor HUMAN PRESCRIPTION DRUG LABEL 11 42494-432 TABLET, CHEWABLE 230 ug ORAL Unapproved drug other 6 sections
Poly-ViFlor HUMAN PRESCRIPTION DRUG LABEL 11 42494-433 TABLET, CHEWABLE 230 ug ORAL Unapproved drug other 6 sections
Poly-ViFlor HUMAN PRESCRIPTION DRUG LABEL 11 42494-434 TABLET, CHEWABLE 230 ug ORAL Unapproved drug other 6 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 16 64661-650 CAPSULE, DELAYED RELEASE PELLETS 5.23 mg ORAL UNAPPROVED DRUG OTHER 11 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 16 64661-650 CAPSULE, DELAYED RELEASE PELLETS 5.23 mg ORAL UNAPPROVED DRUG OTHER 11 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 16 64661-650 CAPSULE, DELAYED RELEASE PELLETS 5.23 mg ORAL UNAPPROVED DRUG OTHER 11 sections
EnLyte HUMAN PRESCRIPTION DRUG LABEL 18 64661-711 CAPSULE, DELAYED RELEASE PELLETS 7 mg ORAL unapproved drug other 12 sections
Biopar delta-FORTE HUMAN PRESCRIPTION DRUG LABEL 6 64661-793 CAPSULE 7 mg ORAL unapproved drug other 11 sections
Biopar delta-FORTE HUMAN PRESCRIPTION DRUG LABEL 6 64661-793 CAPSULE 7 mg ORAL unapproved drug other 11 sections
Biopar delta-FORTE HUMAN PRESCRIPTION DRUG LABEL 6 64661-793 CAPSULE 7 mg ORAL unapproved drug other 11 sections
Prenate Mini HUMAN PRESCRIPTION DRUG LABEL 15 75854-315 CAPSULE, GELATIN COATED 600 ug ORAL unapproved drug other 12 sections
Prenate Pixie HUMAN PRESCRIPTION DRUG LABEL 12 75854-316 TABLET, FILM COATED 600 ug ORAL unapproved drug other 12 sections
Chromagen HUMAN PRESCRIPTION DRUG LABEL 8 75854-320 CAPSULE 750 ug ORAL unapproved drug other 12 sections
Niferex HUMAN PRESCRIPTION DRUG LABEL 9 75854-321 TABLET 750 ug ORAL unapproved drug other 12 sections