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Drug ReportsCholecalciferol
Cholecalciferol
Adrovance, Alendronic Acid / Colecalciferol, Fosamax D, Fosavance, Infuvite, Vantavo (cholecalciferol) is a small molecule pharmaceutical. Cholecalciferol was first approved as Infuvite adult on 2000-05-18. It is used to treat cardiovascular diseases, chronic kidney failure, crohn disease, familial hypophosphatemic rickets, and hypoparathyroidism amongst others in the USA. It has been approved in Europe to treat postmenopausal osteoporosis.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
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Trade Name
FDA
EMA
Combinations
Fosamax d, Infuvite
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Alendronate sodium
+
Cholecalciferol
Tradename
Company
Number
Date
Products
FOSAMAX PLUS DOrganonN-021762 RX2005-04-07
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
3 pack family dollar instant hand sanitizersOTC monograph not final2014-11-28
a and dOTC monograph final2020-01-07
a and d plus eC2002632024-08-08
adult infuvite multiple vitaminsNew Drug Application2019-05-14
adult infuvite multiple vitamins for infusion pharmacy bulkNew Drug Application2013-01-01
ag internationalOTC monograph final2019-07-23
ameridermOTC monograph final2022-01-13
animi-3unapproved drug other2013-02-06
animi-3 with vitamin dunapproved drug other2011-05-23
anubis barcelonaOTC monograph final2023-09-01
Show 180 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic kidney failureEFO_0003884D007676N18.6
cardiovascular diseasesEFO_0000319D002318I98
hypercholesterolemia—D006937—
psoriasisEFO_0000676D011565L40
lung neoplasms—D008175C34.90
crohn diseaseEFO_0000384D003424K50
skin neoplasmsEFO_0004198D012878C44
familial hypophosphatemic rickets—D053098—
osteoporosisEFO_0003882D010024M81.0
hypertriglyceridemiaEFO_0004211D015228—
Show 26 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11C: Vitamin a and d, incl. combinations of the two
— A11CC: Vitamin d and analogues
— A11CC05: Colecalciferol
— A11CC55: Colecalciferol, combinations
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB03: Alendronic acid and colecalciferol
— M05BB04: Risedronic acid, calcium and colecalciferol, sequential
— M05BB05: Alendronic acid, calcium and colecalciferol, sequential
— M05BB07: Risedronic acid and colecalciferol
— M05BB08: Zoledronic acid, calcium and colecalciferol, sequential
— M05BB09: Ibandronic acid and colecalciferol
— M05BX: Other drugs affecting bone structure and mineralization in atc
— M05BX53: Strontium ranelate and colecalciferol
HCPCS
No data
Clinical
Clinical Trials
4494 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoporosisD010024EFO_0003882M81.03—42110
Postmenopausal osteoporosisD015663EFO_0003854———12—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vitamin d deficiencyD014808EFO_0003762E55——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCholecalciferol
INNcolecalciferol
Description
Calciol is a hydroxy seco-steroid that is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene in which the pro-S hydrogen at position 3 has been replaced by a hydroxy group. It is the inactive form of vitamin D3, being hydroxylated in the liver to calcidiol (25-hydroxyvitamin D3), which is then further hydroxylated in the kidney to give calcitriol (1,25-dihydroxyvitamin D3), the active hormone. It has a role as a human metabolite and a geroprotector. It is a seco-cholestane, a hydroxy seco-steroid, a member of D3 vitamins, a secondary alcohol and a steroid hormone.
Classification
Small molecule
Drug classvitamin D analogs
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=C1CC[C@H](O)C/C1=C/C=C1\CCC[C@@]2(C)[C@H]1CC[C@@H]2[C@H](C)CCCC(C)C
Identifiers
PDB—
CAS-ID67-97-0
RxCUI—
ChEMBL IDCHEMBL1042
ChEBI ID28940
PubChem CID5280795
DrugBankDB00169
UNII ID1C6V77QF41 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Cholecalciferol
+
Alendronate
Total medical expenditures per year (USD, in millions)
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Cholecalciferol
Total medical expenditures per year (USD, in millions)
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Cholecalciferol
+
Folic acid
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 102,063 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, O-cal prenatal vitamin, Omega-3 well pack, 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 dha, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Primacare, Select ob, Select-ob plus dha, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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20,687 adverse events reported
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