Quick answers
- What is Hydroxocobalamin (hydroxocobalamin acetate) used for?
- The FDA-approved label (Hydroxocobalamin, Actavis Pharma, Inc., January 31, 2017) says: “Pernicious anemia, both uncomplicated and accompanied by nervous system involvement. Dietary deficiency of Vitamin B 12, occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B 12 deficiency is very rare). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydroxocobalamin (hydroxocobalamin acetate) have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydroxocobalamin (hydroxocobalamin acetate)?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 15, 2026). Ask your pharmacist about alternatives.
- Has Hydroxocobalamin (hydroxocobalamin acetate) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hydroxocobalamin (hydroxocobalamin acetate)?
- 1 company lists prescription products of Hydroxocobalamin (hydroxocobalamin acetate) in the FDA NDC Directory, including Actavis Pharma, Inc..
What Hydroxocobalamin (hydroxocobalamin acetate) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pernicious anemia, both uncomplicated and accompanied by nervous system involvement. Dietary deficiency of Vitamin B 12, occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B 12 deficiency is very rare). …
— FDA label: Hydroxocobalamin, Actavis Pharma, Inc., effective January 31, 2017. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intramuscular |
| Prescription products | 1 in the FDA NDC Directory |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydroxocobalamin acetate 1000 ug/mL injection, solution | Generic | $0.8144 per mL |
NADAC list of November 4, 2026; these prices took effect on March 18, 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.
- Actavis Pharma, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA085998Actavis · August 16, 1978
Shortage status
Current shortage · updated October 15, 2026 · first posted November 4, 2024
| Product | Hydroxocobalamin, Injection, 1000 MCG/ML, 30 ML Multi-Dose Vial (NDC 0591-2888-30) |
|---|---|
| Availability | Unavailable |
| Reason given | Other |
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 317106 |
|---|---|
| SPL set ID of the quoted label | a3087a39-f218-4f16-a1e7-17c39bb2eb69 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | HYDROXOCOBALAMIN ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hydroxocobalamin, Actavis Pharma, Inc., effective January 31, 2017; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →