MedPath

Vitamin D3

Generic Name
Vitamin D3
Brand Names
Adrovance, Animi-3 With Vitamin D, Citranatal B-calm Kit, Citranatal Harmony, Fosamax Plus D, Fosavance, Infuvite, Infuvite Pediatric, Mvc-fluoride, Natafort, Pregvit, Vidextra, Vantavo (previously Alendronate sodium and colecalciferol, MSD)
Drug Type
Small Molecule
Chemical Formula
C27H44O
CAS Number
67-97-0
Unique Ingredient Identifier
1C6V77QF41

Overview

Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .

Indication

Cholecalciferol use is indicated for the treatment of specific medical conditions like refractory rickets (or vitamin D resistant rickets), hypoparathyroidism, and familial hypophosphatemia . Concurrently, as one of the most commonly utilized forms of vitamin D, cholecalciferol is also very frequently used as a supplement in individuals to maintain sufficient vitamin d levels in the body or to treat vitamin D deficiency, as well as various medical conditions that can be associated directly or indirectly with vitamin d insufficiency like osteoporosis and chronic kidney disease, among others .

Associated Conditions

  • Bone Fractures
  • Calcium and Vitamin D Deficiencies
  • Deficiency of Vitamin D3
  • Deficiency, Vitamin A
  • Deficiency, Vitamin D
  • Hip Fracture
  • Hypoparathyroidism
  • Hypophosphatemia, Familial
  • Menopause
  • Osteomalacia
  • Osteoporosis
  • Postmenopausal Osteoporosis
  • Vertebral Fractures
  • Vitamin D Resistant Rickets
  • Vitamin Deficiency
  • Severe Bone Resorption
  • Spine fracture

Research Report

Published: Jul 14, 2025

A Comprehensive Monograph on Cholecalciferol (Vitamin D3): From Molecular Structure to Clinical Application

Executive Summary

Cholecalciferol, commonly known as Vitamin D3, is a fat-soluble secosteroid that functions as a critical prohormone within the human body. While historically classified as a vitamin, its endogenous synthesis in the skin upon exposure to sunlight and its subsequent multi-organ activation into a potent hormone underscore its central role in a complex endocrine system. The primary and undisputed function of the Vitamin D system is the maintenance of calcium and phosphate homeostasis, which is essential for normal bone mineralization. Consequently, Cholecalciferol is a cornerstone therapy for the prevention and treatment of a range of skeletal disorders arising from its deficiency, including rickets in children, osteomalacia in adults, and as an adjunct with calcium for osteoporosis management.

A significant body of scientific evidence has established the clinical superiority of Cholecalciferol (D3) over its plant-derived counterpart, Ergocalciferol (D2). Studies consistently demonstrate that D3 is more potent and has a longer duration of action in raising and sustaining serum concentrations of 25-hydroxyvitamin D, the key indicator of vitamin D status. This has led to a broad consensus that Cholecalciferol should be the preferred form for both supplementation and therapeutic repletion.

Continue reading the full research report

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

Title
Posted
Study ID
Phase
Status
Sponsor
2022/11/14
Phase 3
Recruiting
2022/10/26
Phase 1
Recruiting
2022/10/24
Phase 4
Completed
Department of Endocrinology, Centre of Postgraduate Medical Education
2022/10/13
Phase 2
Completed
2022/09/29
Not Applicable
Completed
2022/09/23
Phase 1
Not yet recruiting
Yangzhou University
2022/07/15
Phase 2
Completed
2022/07/11
Not Applicable
Completed
2022/06/24
Phase 2
Completed
Saiful Anwar Hospital
2022/06/24
Phase 4
Completed

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Cameron Pharmaceuticals
42494-433
ORAL
10 ug in 1 1
9/18/2023
PureTek Corporation
59088-166
ORAL
20 ug in 1 1
2/8/2023
Sandoz Inc
54643-7874
INTRAVENOUS
200 [iU] in 10 mL
10/28/2016
Everett Laboratories, Inc.
0642-0070
ORAL
25 ug in 1 1
9/1/2021
Sandoz Inc
54643-5650
INTRAVENOUS
200 [iU] in 10 mL
3/17/2016
PureTek Corporation
59088-180
ORAL
13.75 ug in 1 1
1/11/2023
PureTek Corporation
59088-018
ORAL
10 ug in 1 1
5/15/2025
H.J. Harkins Company, Inc.
52959-593
ORAL
400 [iU] in 1 mL
10/25/2011
PureTek Corporation
59088-187
ORAL
20 ug in 1 1
1/11/2023
Bryant Ranch Prepack
63629-1138
ORAL
400 [iU] in 1 1
12/30/2021

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Health Canada Drug Approvals

View More Health Canada Approvals

Sign in to access additional Health Canada approved drug information with detailed regulatory data.

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SWISS TOTAL ONE
swiss herbal remedies ltd.
02248627
Tablet - Oral
200.0 UNIT
1/5/2004
PRENAVITE FORTE TABLETS
roberts pharmaceutical canada inc.
02063182
Tablet - Oral
400 UNIT / TAB
12/31/1995
ULTRAVITE FORTE WITH MINERALS 29
stanley pharmaceuticals, a division of vita health products inc.
01994379
Tablet - Oral
400 UNIT
12/31/1992
WOMAN'S DAILY SPECTRUM TABLETS
pharmetics (2011) inc
02240019
Tablet - Oral
200 UNIT / TAB
8/18/1999
SOLOTRON - TAB ORL
general nutrition canada inc.
02228734
Tablet - Oral
400 UNIT
8/1/2000
OSTEO-PLUS
rolmex international inc.
02242649
Tablet - Oral
65 UNIT
9/15/2000
SPECTRUM FORTE 29 TAB
ksl pharmaceuticals
01924877
Tablet - Oral
400 UNIT / TAB
12/31/1991
ONE TABLET DAILY MENS FORMULA
vita health products inc
02247241
Tablet - Oral
400 UNIT
5/16/2003
SUPER DAILY NO 2
w.r. enterprises inc.
00839043
Tablet - Oral
400 UNIT
12/31/1990
PARAMETTES CHEWABLE MULTIVITAMINS PLUS IRON
wyeth-ayerst canada inc.
02043114
Tablet - Oral
400 UNIT / TAB
12/31/1994

CIMA AEMPS Drug Approvals

View More CIMA AEMPS Approvals

Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MASTICAL D 500 mg/ 400 UI COMPRIMIDOS MASTICABLES SABOR NARANJA
65097
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
CADELIUS D 600 MG/2000 UI COMPRIMIDOS BUCODISPERSABLES
85269
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL TECNIGEN 70 MG/5600 UI COMPRIMIDOS EFG
Tecnimede España Industria Farmaceutica S.A.
82759
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLECALCIFEROL NORMON 10.000 UI/ML GOTAS ORALES EN SOLUCIÓN
Laboratorios Normon S.A.
89368
GOTAS ORALES EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
COLECALCIFEROL NORMON 25.000 UI/2,5 ML SOLUCIÓN ORAL
Laboratorios Normon S.A.
90024
SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Commercialized
CARBOCAL D 600 MG/400 UI COMPRIMIDOS MASTICABLES
Farmasierra Laboratorios S.L.
65582
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
DITRALIA 25.000 UI PELICULAS BUCODISPERSABLES
Ibsa Farmaceutici Italia S.R.L.
89921
PELICULA BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLECALCIFEROL GEBRO 50.000 UI SOLUCION ORAL
Laboratorios Gebro Pharma S.A.
88676
SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized
FOSAVANCE 70 MG/5.600 UI COMPRIMIDOS
Organon N.V.
05310007IP3
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL STADA 70 MG/2.800 UI COMPRIMIDOS EFG
Laboratorio Stada S.L.
83548
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

View More Philippines FDA Approvals

Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

View More Saudi SFDA Approvals

Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

View More Malaysia NPRA Approvals

Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

View More UK EMC Drug Information

Sign in to access additional UK EMC drug information with detailed pharmaceutical data.

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.