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Prescription medicine · generic available

Cyanocobalamin

Brand names: Nascobal

Drug class: Vitamin B12

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
5Recalls (FDA reports)
24Companies
1971First FDA approval on file

Quick answers

What is Cyanocobalamin used for?
The FDA-approved label (Nascobal, Par Health USA, LLC, March 1, 2024) says: “NASCOBAL is indicated for: Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Cyanocobalamin have a boxed warning?
No. None of the 33 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Cyanocobalamin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Cyanocobalamin been recalled?
FDA enforcement reports list 5 recalls of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Cyanocobalamin?
24 companies list prescription products of Cyanocobalamin in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., HF Acquisition Co LLC, DBA HealthFirst and Gland Pharma Limited.

What Cyanocobalamin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

NASCOBAL is indicated for: Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 …

— FDA label: Nascobal, Par Health USA, LLC, effective March 1, 2024. Read the full label on DailyMed →

The FDA has 33 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 33 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection · Spray · Spray, metered
RouteIntramuscular · Subcutaneous · Nasal
Prescription products52 in the FDA NDC Directory
Brand namesNascobal

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Cyanocobalamin, by strength and form
Strength and formGeneric or brandPharmacies pay
cyanocobalamin 1000 ug/mL
injection		 Generic $0.3281–$1.45 per mL
13 packages, lowest to highest
cyanocobalamin 1000 ug/mL
injection, solution		 Generic $0.3281–$3.14 per mL
16 packages, lowest to highest
cyanocobalamin 500 ug
spray		 Generic $86.43 per unit

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021642
NASCOBAL		 Endo OperationsJanuary 31, 2005 10, latest December 7, 2018
2018: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC)

Generic approvals (15)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. July 24, 2026 · Class II · Ongoing · D-0792-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11 — American Regent, Inc.

  2. July 24, 2026 · Class II · Ongoing · D-0793-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, — American Regent, Inc.

  3. April 5, 2022 · Class III · Terminated · D-0766-2022

    Subpotent Drug: Out of Specification results for Assay

    Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01. — Aurobindo Pharma USA Inc.

  4. March 15, 2021 · Class II · Terminated · D-0595-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL — Cardinal Health Inc.

  5. September 27, 2012 · Class II · Terminated · D-0297-2015

    Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

    CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01. — Fresenius Kabi USA, LLC

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)309594, 861113, 861115
SPL set ID of the quoted label697e0e52-c01b-4b53-9994-f79c46eb6b4f
FDA labels (SPL)33
FDA applicationsNDA021642, 15 ANDA
Active ingredients (FDA)CYANOCOBALAMIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Nascobal, Par Health USA, LLC, effective March 1, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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