Vitamin B12

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 .

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
THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES	2025/06/25	NCT07036497	N/A	Completed	OZGUR EKICI
Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury	2023/07/24	NCT05958277	Phase 3	Completed	KRL Hospital, Islamabad
Intrathecal Pemetrexed for Leptomeningeal Metastasis	2022/03/22	NCT05289908	Phase 1	Completed	The First Hospital of Jilin University
Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo	2022/02/03	NCT05221892	Phase 4	Completed	Fundação Educacional Serra dos Órgãos
GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response	2020/05/13	NCT04387201	Phase 4	Completed	The University of Texas Health Science Center, Houston
Vitamin B12 for Carpal Tunnel Syndrome	2019/01/14	NCT03802422	Not Applicable	Withdrawn	Tri-Service General Hospital
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics	2018/12/31	NCT03790345	Phase 2	UNKNOWN	Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Effects of Vitamin B12 Treatment in Singers	2018/02/19	NCT03437824	Early Phase 1	Completed	University of Southern California
Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer	2017/04/05	NCT03101579	Phase 1	Completed	The First Hospital of Jilin University
Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine	2016/05/16	NCT02773147	Phase 2	UNKNOWN	Göteborg University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PRENATAL PLUS	AvPAK	50268-677	ORAL	12 ug in 1 1	4/12/2022
Vitamin Deficiency System	IT3 Medical LLC	70529-293	INTRAMUSCULAR, SUBCUTANEOUS	1000 ug in 1 mL	8/17/2018
Quflora Pediatric	CarWin Pharmaceutical Associates, LLC	15370-105	ORAL	4 ug in 1 1	1/10/2024
CitraNatal Bloom	Mission Pharmacal Company	0178-0813	ORAL	16.8 ug in 1 1	1/5/2024
Multivitamin with Fluoride	Method Pharmaceuticals, LLC	58657-164	ORAL	4.5 ug in 1 1	12/9/2023
Niferex	Avion Pharmaceuticals, LLC	75854-344	ORAL	25 ug in 1 1	4/8/2025
Vitafol Fe Plus	Exeltis USA, Inc.	0642-7473	ORAL	25 ug in 1 1	2/14/2023
BACMIN	Marnel Pharmaceuticals, Inc.	0682-3001	ORAL	50 ug in 1 1	5/2/2014
C-Nate DHA	Centurion Labs, LLC	23359-105	ORAL	15 ug in 1 1	1/22/2024
Chromagen	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	PT. HEXPHARM JAYA LABORATORIES	SIN12077P	TABLET, FILM COATED	200 mcg	9/17/2002
NUTRIHEALTH NEUROVIT FORTE TABLET	HOVID BHD, HOVID Bhd.	SIN10260P	TABLET, FILM COATED	1.0 mg	10/14/1998
NUTRIHEALTH NEUROVIT TABLET	HOVID BHD	SIN10261P	TABLET, FILM COATED	100 mcg	10/14/1998
ENZYPLEX TABLET	PT MEDIFARMA LABORATORIES INC	SIN06211P	ENTERIC COATED TABLET	5 mcg	5/3/1991
NEUROBION TABLET	P&G Health Austria GmbH Co. OG	SIN06258P	TABLET, SUGAR COATED	200 mcg	6/21/1991
NEUROBION INJECTION	Merck Healthcare KGaA	SIN06262P	INJECTION	1 mg/3 ml	6/21/1991
VITAMIN B FORTE TABLET	PT ACTAVIS INDONESIA	SIN07635P	TABLET, FILM COATED	1000 mcg	2/4/1994
FBC FILMTAB	OLIC (THAILAND) LTD, UNICHEM PHARMACEUTICALS LTD	SIN05814P	TABLET, FILM COATED	5 mcg	5/3/1991
TAMIPOOL FOR INJECTION	CELLTRION PHARM, INC.	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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
NEW-PAIN-Q CAP	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	6/20/1990
SUMITON CAPSULE (NEW FORMULA)	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	6/17/2014
MULTIMAX SYRUP	N/A	VICKMANS LABORATORIES LIMITED	N/A	N/A	7/8/2014
CERNEVIT FOR INJ	N/A	Baxter Healthcare Ltd	N/A	N/A	4/18/2008
BIOCATALIN INJECTABLE SOLN (VET)	N/A	WAI LUNG HONG AGRIBUSINESS LIMITED	N/A	N/A	8/9/1984
TELING EYE DROPS	N/A	SATO PHARMACEUTICAL CO.,LTD.	N/A	N/A	12/8/1992
NOARL ONE N EYE DROPS	N/A	SATO PHARMACEUTICAL CO.,LTD.	N/A	N/A	12/5/2001
WHARNIS (NEW FORMULA) CAPSULES	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	11/29/2013
HEPATOSWISS FOR IV INFUSION INJ	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/12/1982
HEPATOSWISS IM INJ	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	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	Caruso's Natural Health Pty Ltd	Medicine	A	3/9/2017
BLACKMORES SUPERKIDS MULTI CHEWABLES	289492	Blackmores Ltd	Medicine	A	5/30/2017
Super B Complex tablets	126510	Sphere Healthcare Pty Ltd	Medicine	A	3/28/2006
BLACKMORES B+C TABLETS	215811	Blackmores Ltd	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	Blackmores Ltd	Medicine	A	8/29/2007
Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs	139048	Universal Pharmaceuticals Pty Ltd	Medicine	A	5/21/2007
Berocca Performance Original effervescent tablets	193893	Bayer Australia Ltd	Medicine	A	1/17/2012
Cenovis Iron Plus	265482	Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare	Medicine	A	12/4/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
C.E.B12 COMPLEX PWR	pure life international prods inc.	02051117	Powder - Oral	1.8 MCG / G	12/31/1993
CENTURY PLUS	vita health products inc	N/A	Tablet - Oral	9 MCG / TAB	2/5/1998
STRESS B COMPLEX WITH C AND E TAB	PHARMAVITE LLC	02008947	Tablet - Oral	12 MCG / TAB	12/31/1993
STRESS B CAPSULES WITH VITAMIN C	rheingold food international ltd.	00694509	Capsule - Oral	250 MCG / CAP	12/31/1987
MULTIPLE VITAMINS PLUS IRON FOR WOMEN	pharmetics (2011) inc	02239678	Tablet - Oral	6 MCG / TAB	8/16/1999
MOR-VITES TAB	pharmetics (2011) inc	01911236	Tablet - Oral	3 MCG	12/31/1992
LIQUI B COMPLEX PLUS	twin laboratories inc.	01984411	Liquid - Oral	10 MCG / ML	12/31/1995
VITAMIN B12 SRT 1000MCG	anabolic laboratories inc.	00527378	Tablet (Extended-Release) - Oral	1 MG / TAB	12/31/1981
VITAMIN B12 TABLETS 250MCG	london drugs limited	00879932	Tablet - Oral	250 MCG / TAB	10/11/1996
POLYMINE AVEC ZINC ET CUIVRE	les laboratoires vachon inc.	00630888	Tablet - Oral	12 MCG	12/31/1985

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
VITAGOBENS B1 B6 B12 COMPRIMIDOS RECUBIERTOS CON PELICULA	Laboratorios Normon S.A.	86153	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Commercialized
BECOZYME C FORTE COMPRIMIDOS RECUBIERTOS	Bayer Hispania S.L.	40869	COMPRIMIDO RECUBIERTO	Sin Receta	Commercialized
CERNEVIT POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Baxter S.L.	60022	LIOFILIZADO PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
ELEVIT COMPRIMIDOS RECUBIERTOS CON PELICULA	Bayer Hispania S.L.	67267	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Not Commercialized
NERVOBION 5000 SOLUCIÓN INYECTABLE	Laboratorios Vicks S.L.	45113	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OPTOVITE B12 1.000 MICROGRAMOS SOLUCIÓN INYECTABLE	Laboratorios Normon S.A.	48877	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
HIDROXIL B1-B6-B12 COMPRIMIDOS RECUBIERTOS CON PELICULA	Almirall S.A.	79062	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Commercialized
FOLI-DOCE 400/2 MICROGRAMOS COMPRIMIDOS	Itf Abacus Farma S.A.	63022	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CROMATONBIC B12 1000 INYECTABLE	Laboratorios Menarini S.A.	52435	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
PANTOBAMIN SOLUCION	Medix S.A.	48988	GOTAS ORALES EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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

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