Cyanocobalamin

Treats dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to…. Sold as Redisol, Berubigen, Rubramin Pc, Vi-Twel, Cyanocobalamin and 3 more. Every FDA application for this active ingredient: 9 branded and 36 generic.

As of Nov 15, 2026, FDA lists 45 applications for Cyanocobalamin (sold as Redisol, Berubigen, Rubramin Pc and others), first approved Sep 15, 1949, with 1 new use approved and 0 published complete response letters.

First approved: Sep 15, 1949
Applications: 45
New uses approved: 1
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CYANOCOBALAMIN 1,000 MCG/ML VL: $1.45 per MLGeneric · -10% in a year
CYANOCOBALAMIN 10,000 MCG/10 ML: $2.64 per MLGeneric · +81% in a year
CYANOCOBALAMIN 30,000 MCG/30 ML: $0.800 per MLGeneric · +12% in a year
CYANOCOBALAMIN 500 MCG SPRAY: $86.43 per unitGeneric · -13% in a year

Clinical Trials

110 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effectiveness and Safety of Cellbooster Hair in Healthy SubjectsHair and Scalp Health · Suisselle	Not applicable	Not yet recruiting	Nov 10, 2026
Oral B-Complex Vitamin (B6, B9 and B12) Prevents Low Anterior Resection Syndrome in Rectal Cancer Patients With HyperhomocysteinemiaLow Anterior Resection Syndrome, Hyperhomocysteinemia · Qilu Hospital of Shandong University	Not applicable	Not yet recruiting	Nov 10, 2026
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control TrialOral and Maxillofacial Conditions · Dow University of Health Sciences	Phase 2	Not yet recruiting	Nov 6, 2026
Stanford University Neurofiber StudyPARKINSON DISEASE (Disorder) · Stanford University	Phase 1	Not yet recruiting	Nov 3, 2026
Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-ThalassemiaBeta-Thalassemia, Thalassemia · Khyber Medical University Peshawar	Phase 3	Recruiting	Oct 21, 2026
Methyl Donor-Rich Diet in the Postpartum PeriodPostpartum Depression (PPD), Breastfeeding · Istanbul University - Cerrahpasa	Not applicable	Recruiting	Oct 21, 2026
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound HealingDiabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy · BREGO Life Sciences	Not applicable	Recruiting	Oct 16, 2026
Unflavored Powdered Multivitamin in ChildrenSelective Eating, Emotional Dysregulation · EllaOla	Not applicable	Not yet recruiting	Oct 7, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 15, 1949	Vi-TwelNDA 7012	Bayer Hlthcare	0	Discontinued
Dec 6, 1949	CyanocobalaminNDA 7085	Warner Chilcott	2	Discontinued
Sep 29, 1950	Rubramin PcNDA 6799 · New formulation or manufacturer	Bristol Myers Squibb	11	Discontinued
Jul 14, 1958	RubiviteNDA 10791 · New formulation or manufacturer	Bel Mar	0	Discontinued
Oct 20, 1971	CyanocobalaminANDA 80515	West-Ward Pharms Int	14	Marketed
Apr 26, 1972	CyanocobalaminANDA 80737	Am Regent	21	Marketed
Sep 20, 1972	DodexANDA 83022	Accord Hlthcare	1	Discontinued
Mar 21, 1973	CyanocobalaminANDA 80554	Wyeth Ayerst	2	Discontinued
Jun 20, 1973	Cyanocobalamin, VibisoneANDA 80557	Fresenius Kabi USA	10	Marketed
Jun 22, 1973	CyanocobalaminANDA 80689	Dell Labs	0	Discontinued
Jul 9, 1973	Betalin 12ANDA 80855	Lilly	0	Discontinued
Jan 29, 1974	CyanocobalaminANDA 80573	Dr Reddys	20	Discontinued
Sep 12, 1979	CyanocobalaminANDA 83075	Lyphomed	0	Discontinued
Nov 5, 1996	NascobalNDA 19722 · New dosage form	Endo Operations	5	Discontinued
Sep 23, 2003	CyanocobalaminANDA 40451	Mylan Institutional	0	Discontinued
Jan 31, 2005	NascobalNDA 21642 · New dosage form	Endo Operations	10	Discontinued
Jul 27, 2007	CalomistNDA 22102 · New formulation or manufacturer	Ph Health	2	Discontinued
Dec 11, 2015	CyanocobalaminANDA 206503	Somerset Theraps LLC	3	Marketed
Jun 5, 2017	CyanocobalaminANDA 204829	Pharmobedient	0	Discontinued
Dec 18, 2018	CyanocobalaminANDA 209255	H2-Pharma	0	Marketed
Dec 18, 2018	CyanocobalaminANDA 209429	Somerset Theraps LLC	0	Marketed
Sep 9, 2020	CyanocobalaminANDA 212458	Padagis Israel	0	Marketed
Sep 24, 2020	CyanocobalaminANDA 214390	Gland	3	Marketed
Dec 8, 2020	CyanocobalaminANDA 213874	Eugia Pharma	1	Marketed
Jan 4, 2021	CyanocobalaminANDA 212915	Sandoz	0	Marketed
Aug 20, 2021	CyanocobalaminANDA 215046	Xiromed	0	Discontinued
Apr 15, 2022	CyanocobalaminANDA 214655	Zydus Pharms	0	Marketed
Apr 15, 2022	CyanocobalaminANDA 215417	Sola Pharms	0	Marketed
Nov 15, 2022	CyanocobalaminANDA 215107	Sagent Pharms Inc	0	Marketed
Jun 30, 2023	CyanocobalaminANDA 210629	Lupin	0	Marketed
Jul 10, 2024	CyanocobalaminANDA 217839	Mankind Pharma	1	Marketed
Nov 15, 2024	CyanocobalaminANDA 214316	Meitheal	0	Marketed
Jul 8, 2026	CyanocobalaminANDA 219820	Aspiro	0	Marketed
—	RedisolNDA 6668	Merck	0	Discontinued
—	BerubigenNDA 6798	Pharmacia And Upjohn	0	Discontinued
—	CyanocobalaminANDA 80510	Abraxis Pharm	0	Discontinued
—	CyanocobalaminANDA 80564	Sanofi Aventis US	1	Discontinued
—	RuviteANDA 80570	Savage Labs	0	Discontinued
—	CyanocobalaminANDA 80668	Luitpold	0	Discontinued
—	CobaviteANDA 83013	Watson Labs	0	Discontinued
—	CobaviteANDA 83064	Watson Labs	0	Discontinued
—	CyanocobalaminANDA 83120	Watson Labs	0	Discontinued
—	CyanocobalaminANDA 84264	West Ward	1	Discontinued
—	CyanocobalaminANDA 87551	Solopak	0	Discontinued
—	CyanocobalaminANDA 87969	Epic Pharma LLC	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA