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Vitamin B12

Generic Name
Vitamin B12
Brand Names
Infuvite Pediatric, Mvc-fluoride, Animi-3 With Vitamin D, Dodex, Fortaplex, Irospan 24/6 Kit, Cobex, Natafort, Infuvite, Vitafol-one, Nascobal, Mvi Pediatric, Hematogen, Folbic, Ferralet 90, Foltabs, Concept Ob, Pregvit, Tandem Plus, B-12
Drug Type
Small Molecule
Chemical Formula
C62H88CoN13O14P
CAS Number
13408-78-1
Unique Ingredient Identifier
8406EY2OQA

Overview

Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria , and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The cyano form, is the most widely used form in supplements and prescription drugs , . Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms , , . This drug was initially approved by the FDA in 1942 .

Background

Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria , and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The cyano form, is the most widely used form in supplements and prescription drugs , . Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms , , . This drug was initially approved by the FDA in 1942 .

Indication

Nasal spray The cyanocobalamin nasal spray is indicated for the maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with deficiency of this vitamin who have no nervous system involvement . Note: CaloMist , the nasal spray form, has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency. Injection forms (subcutaneous, intramuscular) These forms are indicated for vitamin B12 deficiencies due to various causes, with or without neurologic manifestations . Vitamin B12 deficiency is frequently caused by malabsorption, which is often associated with the following conditions : Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of the pancreas or bowel Folic acid deficiency Oral forms Vitamin B12 supplements are widely available and indicated in patients who require supplementation for various reasons. Dose requirements for vitamin B12 which are higher than normal (caused by pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be achieved with oral supplementation . Oral products of vitamin B12 are not recommended in patients with malabsorption, as these forms are primarily absorbed in the gastrointestinal tract .

Associated Conditions

  • Neuritis
  • Vitamin Deficiency
  • Vitamin B6 Deficiency
  • Diabetic Neuropathies
  • Vitamin B1 deficiency
  • Anemia, Pernicious
  • Vitamin B12 Deficiency
  • Convalescence
  • Iron Deficiency Anemia (IDA)
  • Folate deficiency
  • Combined Vitamin B1 and B12 deficiency
  • Vitamin B12 concentration
  • Anemia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/25
N/A
Completed
OZGUR EKICI
2023/07/24
Phase 3
Completed
KRL Hospital, Islamabad
2022/03/22
Phase 1
Completed
2022/02/03
Phase 4
Completed
2020/05/13
Phase 4
Completed
2019/01/14
Not Applicable
Withdrawn
2018/12/31
Phase 2
UNKNOWN
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
2018/02/19
Early Phase 1
Completed
2017/04/05
Phase 1
Completed
2016/05/16
Phase 2
UNKNOWN
Göteborg University

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvPAK
50268-677
ORAL
12 ug in 1 1
4/12/2022
IT3 Medical LLC
70529-293
INTRAMUSCULAR, SUBCUTANEOUS
1000 ug in 1 mL
8/17/2018
CarWin Pharmaceutical Associates, LLC
15370-105
ORAL
4 ug in 1 1
1/10/2024
Mission Pharmacal Company
0178-0813
ORAL
16.8 ug in 1 1
1/5/2024
Method Pharmaceuticals, LLC
58657-164
ORAL
4.5 ug in 1 1
12/9/2023
Avion Pharmaceuticals, LLC
75854-344
ORAL
25 ug in 1 1
4/8/2025
Exeltis USA, Inc.
0642-7473
ORAL
25 ug in 1 1
2/14/2023
Marnel Pharmaceuticals, Inc.
0682-3001
ORAL
50 ug in 1 1
5/2/2014
Centurion Labs, LLC
23359-105
ORAL
15 ug in 1 1
1/22/2024
Avion Pharmaceuticals, LLC
75854-320
ORAL
10 ug in 1 1
1/18/2021

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
VITAMIN B12 INJECTION 1000 mcg/ml
ATLANTIC LABORATORIES CORPN LTD
SIN07876P
INJECTION
1000 mcg/ml
10/20/1994
DANEURON TABLET
SIN12077P
TABLET, FILM COATED
200 mcg
9/17/2002
NUTRIHEALTH NEUROVIT FORTE TABLET
SIN10260P
TABLET, FILM COATED
1.0 mg
10/14/1998
NUTRIHEALTH NEUROVIT TABLET
SIN10261P
TABLET, FILM COATED
100 mcg
10/14/1998
ENZYPLEX TABLET
SIN06211P
ENTERIC COATED TABLET
5 mcg
5/3/1991
NEUROBION TABLET
SIN06258P
TABLET, SUGAR COATED
200 mcg
6/21/1991
NEUROBION INJECTION
SIN06262P
INJECTION
1 mg/3 ml
6/21/1991
VITAMIN B FORTE TABLET
SIN07635P
TABLET, FILM COATED
1000 mcg
2/4/1994
FBC FILMTAB
SIN05814P
TABLET, FILM COATED
5 mcg
5/3/1991
TAMIPOOL FOR INJECTION
SIN11849P
INJECTION, POWDER, FOR SOLUTION
5 mcg/vial
3/15/2002

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Vitamin B12 Solution
国药准字H10940197
化学药品
溶液剂
8/21/2020
Vitamin B12 Injection
国药准字H44022068
化学药品
注射剂
7/30/2020
Vitamin B12 Injection
国药准字H37022955
化学药品
注射剂
7/25/2023
Vitamin B12 Injection
国药准字H44022100
化学药品
注射剂
3/10/2020
Vitamin B12 Injection
国药准字H43021482
化学药品
注射剂
8/4/2020
Vitamin B12 Injection
国药准字H37021054
化学药品
注射剂
5/8/2020
Vitamin B12 Injection
国药准字H44022524
化学药品
注射剂
1/6/2020
Vitamin B12 Injection
国药准字H41020634
化学药品
注射剂
1/8/2020
Vitamin B12 Injection
国药准字H45020962
化学药品
注射剂
9/29/2020
Vitamin B12 Injection
国药准字H53021284
化学药品
注射剂
9/28/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
NEW-PAIN-Q CAP
N/A
unicorn laboratories o/b american unicorn laboratories limited
N/A
N/A
6/20/1990
SUMITON CAPSULE (NEW FORMULA)
N/A
europharm lab co ltd
N/A
N/A
6/17/2014
MULTIMAX SYRUP
N/A
vickmans laboratories ltd
N/A
N/A
7/8/2014
CERNEVIT FOR INJ
N/A
N/A
N/A
4/18/2008
BIOCATALIN INJECTABLE SOLN (VET)
N/A
wai lung hong agribusiness ltd
N/A
N/A
8/9/1984
TELING EYE DROPS
N/A
sato pharmaceutical (hk) co ltd
N/A
N/A
12/8/1992
NOARL ONE N EYE DROPS
N/A
sato pharmaceutical (hk) co ltd
N/A
N/A
12/5/2001
WHARNIS (NEW FORMULA) CAPSULES
N/A
europharm lab co ltd
N/A
N/A
11/29/2013
HEPATOSWISS FOR IV INFUSION INJ
N/A
wilcome pharmaceutical co ltd
N/A
N/A
11/12/1982
HEPATOSWISS IM INJ
N/A
wilcome pharmaceutical co ltd
N/A
N/A
8/13/1982

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Cellula-T oral powder jar
43995
Hong Sp & Hs
Medicine
A
4/13/1993
Caruso's St John's Wort
286553
Medicine
A
3/9/2017
BLACKMORES SUPERKIDS MULTI CHEWABLES
289492
Medicine
A
5/30/2017
Super B Complex tablets
126510
Medicine
A
3/28/2006
BLACKMORES B+C TABLETS
215811
Medicine
A
10/9/2013
MaxN-Fuze Multivitamins
288444
Max Health & Living Australia Pty Ltd
Medicine
A
5/1/2017
Blackmores Bio Iron (NZ)
143952
Medicine
A
8/29/2007
Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs
139048
Medicine
A
5/21/2007
Berocca Performance Original effervescent tablets
193893
Medicine
A
1/17/2012
Cenovis Iron Plus
265482
Medicine
A
12/4/2015
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