Cyanocobalamin 1000 ug/mL Injection, Solution, 25 vials
Other active recalls for Cyanocobalamin (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Vitamin B12 class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's a prescription form of vitamin B12, used when your body can't get enough B12 on its own. That can happen because of a condition called pernicious anemia — where your stomach c...
- What is cyanocobalamin actually used for?
- The injection goes directly into a muscle or under the skin, bypassing the gut entirely — which makes it the most reliable option, especially for pernicious anemia, where lifelong...
- What's the difference between the shot and the nasal spray?
Patient education
Supplement & herbal interactions
Where does this data come from?
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💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.494 | $37.35 / 25 ml |
| Medicaid paysCMS SDUD · 12 mo | $4.38 | $109.50 / 25 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3420 | $0.683 / J3420 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cyanocobalamin 1000 ug/mL 00143-9619-10 | Hikma | 10 vials | $0.328 | AP | Availability likely | save 78% |
| Cyanocobalamin 1000 ug/mL 69680-0121-05 | Vitruvias | 5 vials | $0.549 | AP | Availability likely | save 63% |
| cyanocobalamin 1000 ug/mL 70710-1665-01 | Zydus | 1 vial | $0.761 | AP | Availability likely | save 49% |
| Cyanocobalamin 1000 ug/mL 00143-9620-10 | Hikma | 10 vials | $0.777 | AP | Availability likely | save 48% |
| Cyanocobalamin 1000 ug/mL 69680-0113-99 | Vitruvias | 10 vials | $0.777 | AP | Availability likely | save 48% |
| cyanocobalamin 1000 ug/mL 70069-0172-10 | Somerset | 10 vials | $0.777 | AP | Availability likely | save 48% |
| Cyanocobalamin 1000 ug/mL 71288-0301-11 | Meitheal | 10 vials | $0.777 | AP | Availability likely | save 48% |
| Cyanocobalamin 1000 ug/mL 00517-0130-01 | American | 1 vial | $0.794 | AP | Availability likely | save 47% |
| Cyanocobalamin 1000 ug/mL 71288-0302-30 | Meitheal | 1 vial | $0.794 | AP | Availability likely | save 47% |
| cyanocobalamin 1000 ug/mL 70710-1664-06 | Zydus | 10 vials | $0.819 | AP | Availability likely | save 45% |
| cyanocobalamin 1000 ug/mL 70710-1663-07 | Zydus | 25 vials | $1.491 | AP | Availability likely | +0% |
| Cyanocobalamin 1000 ug/mL 00143-9621-25 | Hikma | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 00517-0031-25 | American | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 25021-0502-01 | Sagent | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 63323-0044-01 | Fresenius | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 68001-0542-60 | BluePoint | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 68001-0640-60 | BluePoint | 25 vials | $1.494 | AP | Availability likely | — |
| cyanocobalamin 1000 ug/mL 70069-0005-10 | Somerset | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 70512-0840-25 | SOLA | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mLthis 70756-0635-25 | Lifestar | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 71288-0300-92 | Meitheal | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 71288-0303-02 | Meitheal | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 72603-0650-25 | NorthStar | 25 vials | $1.494 | AP | Availability likely | — |
| Cyanocobalamin 1000 ug/mL 00517-0032-25 | American | 25 vials | $2.134 | AP | Availability likely | +43% |
| Cyanocobalamin 1000 ug/mL 69680-0112-10 | Vitruvias | 10 vials | $2.909 | AP | Availability likely | +95% |
| Cyanocobalamin 1000 ug/mL 00404-9783-30 | Henry | 1 vial | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 00404-9786-10 | Henry | 1 vial | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 50090-6229-00 | A-S | 25 vials | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 51662-1394-01 | HF | 30 ml | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 51662-1440-01 | HF | 10 ml | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 51662-1647-03 | HF | 25 pouches | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 51662-1703-03 | HF | 10 pouches | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 55150-0364-01 | AuroMedics | 1 vial | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 68083-0449-25 | Gland | 25 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 68083-0561-25 | Gland | 25 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 68083-0562-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 70069-0171-05 | Somerset | 5 vials | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 70756-0636-10 | Lifestar | 10 vials | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 70756-0637-05 | Lifestar | 5 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 70771-1688-07 | Zydus | 25 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 70771-1689-06 | Zydus | 10 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 70771-1690-01 | Zydus | 1 vial | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 76420-0075-25 | Asclemed | 25 vials | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 76420-0111-25 | Asclemed | 25 vials | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 76420-0618-25 | Asclemed | 25 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 85766-0029-25 | Sportpharm | 25 vials | — | AP | FDA listed | — |
| Cyanocobalamin 1000 ug/mL 87188-0111-90 | Plano | 25 vials | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 87188-0112-01 | Plano | 1 vial | — | AP | FDA listed | — |
| cyanocobalamin 1000 ug/mL 87188-0113-01 | Plano | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 70756-0635-10 | 10 VIAL in 1 CARTON (70756-635-10) / 1 mL in 1 VIAL | — | — | 2024-07-10 | Active |
| 70756-0635-25 You're viewing this | 25 VIAL in 1 CARTON (70756-635-25) / 1 mL in 1 VIAL | $1.49 / mL | $37.35 | 2024-07-10 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 70756-0635-25?
What is the difference between NDC 70756-0635-25 and NDC 70756-0635-10?
What NDC number is used to bill for this package of Cyanocobalamin 1000 ug/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue.
Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the vitamin B 12 absorption test (Schilling test).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Avoid using the intravenous route. Use of this product intravenously will result in almost all of the vitamin being lost in the urine. Pernicious Anemia: Parenteral vitamin B 12 is the recommended treatment and will be required for the remainder of the patient's life.
The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks.
By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed.
Patients with Normal Intestinal Absorption: Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B 12 preparation. If other vitamin deficiencies are present, they should be treated.
Schilling Test: The flushing dose is 1,000 mcg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B 12 is a contraindication.
⚠️ Warnings ▾
WARNINGS Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral vitamin B 12 administration.
An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains Benzyl Alcohol. Benzyl Alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Generalized: Anaphylactic shock and death have been reported with administration of parenteral vitamin B 12 (see WARNINGS ). Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological: Polycythemia vera Gastrointestinal: Mild transient diarrhea Dermatological: Itching; transitory exanthema Miscellaneous: Feeling of swelling of entire body To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE No overdosage has been reported with this drug.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Vitamin B 12 is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within 1 hour after intramuscular injection. Absorbed vitamin B 12 is transported via specific B 12 binding proteins, transcobalamin I and II to the various tissues.
The liver is the main organ for vitamin B 12 storage. Within 48 hours after injection of 100 or 1,000 mcg of vitamin B 12 , 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours.
Intravenous administration results in even more rapid excretion with little opportunity for liver storage. Gastrointestinal absorption of vitamin B 12 depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord.
Prompt parenteral administration of vitamin B 12 prevents progression of neurologic damage. The average diet supplies about 5 to 15 mcg/day of vitamin B 12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B 12 is not present in foods of plant origin, but is abundant in foods of animal origin.
In people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including no milk products or eggs). Vitamin B 12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B 12 enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins.
A small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. Oral absorption is considered too undependable to rely on in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin B 12 . Cyanocobalamin is the most widely used form of vitamin B 12 , and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract.
Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cyanocobalamin injection, USP 1,000 mcg/mL is a red color solution, and is supplied as follows: NDC 70756-635-10 1 mL Multiple-Dose Vial Carton of 10 Vials NDC 70756-635-25 1 mL Multiple-Dose Vial Carton of 25 Vials NDC 70756-636-10 10 mL Multiple-Dose Vial Carton of 10 Vials NDC 70756-636-25 10 mL Multiple-Dose Vial Carton of 25 Vials NDC 70756-637-88 30 mL Multiple-Dose Vial Carton of 1 Vial NDC 70756-637-05 30 mL Multiple-Dose Vial Carton of 5 Vials NDC 70756-637-10 30 mL Multiple-Dose Vial Carton of 10 Vials Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
PROTECT THE PRODUCT FROM LIGHT. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of France Revised: January 2025, V-03
📋 Description ▾
DESCRIPTION Cyanocobalamin injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.50%.
Benzyl Alcohol, 1.5%, is present as a preservative. Sodium acetate and glacial acetic acid are present as buffer. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0).
Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). The vitamin B 12 coenzymes are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.34%. The molecular weight is 1355.39.
The structural formula is represented below. structure