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

Stem definition	Drug id	CAS RN
	4621	31690-09-2

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
Sept. 24, 2010	FDA	BAYER HLTHCARE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN					WOMBAT-PK

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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