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 |
|---|---|
|
Synonyms:
|
an ingredient in Contraceptives, Oral, Combined
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 | 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 |