HomeNDC LookupIngredientsCyanocobalamin › 70069-0171-05
CYANOCOBALAMIN 1000 ug/mL Injection, Solution — NDC 70069-0171-05 package photo

CYANOCOBALAMIN 1000 ug/mL Injection, Solution

by Somerset Therapeutics, LLC · 5 VIAL in 1 CARTON (70069-171-05) / 30 mL in 1 VIAL
NDC 70069-0171-05
🏷️ FDA NDC (as labeled) 70069-171-05 billing pads the product segment with a zero
This package
Contains30 mL in 1 vial Pack sizes2 compare ↓
Also comes in: 10 vials 70069-0171-10
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Cyanocobalamin (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0793-2026
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0792-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70069-171-05
Product NDC 70069-171
11-digit billing NDC 70069017105
RxCUI 309594
UNII P6YC3EG204
UPC 0370069171011, 0370069171059, 0370069171103
Application # ANDA209429
SPL Set ID 617e44f8-df80-4764-85b9-be0fb6da8db3
Established class (EPC) Vitamin B12
Chemical class Vitamin B 12
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-18
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance CYANOCOBALAMIN
GPI-14 82100010002015
GPI class Cyanocobalamin
GCN Seq No 002329
GCN 94594
HICL code 001053
Ingredient (HICL) Cyanocobalamin (Vitamin B-12)
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6L
Therapeutic class — specific (HIC3) Vitamin B12 Preparations
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name CYANOCOBALAMIN 30,000 MCG/30ML
FDB brand name Cyanocobalamin Injection
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 70069-171-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70069-0171-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Vitamin B12 class.

Pharmacologic class Vitamin B12
Drug family (ATC) Vitamin B12 (cyanocobalamin and analogues)
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA209429 (ANDA)
Labeler code70069
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio182 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CYANOCOBALAMIN 30,000 MCG/30ML Ingredient Cyanocobalamin (Vitamin B-12)
📖 What it is MedlinePlus · NLM

Cyanocobalamin injection is used to treat and prevent a lack of vitamin B12 that may be caused by any of the following: pernicious anemia (lack of a natural substance needed to absorb vitamin B12 from the intestine); certain diseases, infections, or medications that decrease the amount of vitamin B12 absorbed from food; or a vegan diet (strict vegetarian diet that does not allow any animal products, including dairy products and eggs). Lack of vitamin B12 may cause anemia (condition in which the red blood cells do not bring enough oxygen to the organs) and permanent damage to the nerves. Cyanoc...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Cyanocobalamin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Red
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 15 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyanocobalamin 1000 ug/mL 00143-9619-10 Hikma 10 vials $0.328 AP Availability likely
Cyanocobalamin 1000 ug/mL 69680-0121-05 Vitruvias 5 vials $0.549 AP Availability likely
cyanocobalamin 1000 ug/mL 70710-1665-01 Zydus 1 vial $0.761 AP Availability likely
Cyanocobalamin 1000 ug/mL 00143-9620-10 Hikma 10 vials $0.777 AP Availability likely
Cyanocobalamin 1000 ug/mL 69680-0113-99 Vitruvias 10 vials $0.777 AP Availability likely
cyanocobalamin 1000 ug/mL 70069-0172-10 Somerset 10 vials $0.777 AP Availability likely
Cyanocobalamin 1000 ug/mL 71288-0301-11 Meitheal 10 vials $0.777 AP Availability likely
Cyanocobalamin 1000 ug/mL 00517-0130-01 American 1 vial $0.794 AP Availability likely
Cyanocobalamin 1000 ug/mL 71288-0302-30 Meitheal 1 vial $0.794 AP Availability likely
cyanocobalamin 1000 ug/mL 70710-1664-06 Zydus 10 vials $0.819 AP Availability likely
cyanocobalamin 1000 ug/mL 70710-1663-07 Zydus 25 vials $1.491 AP Availability likely
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/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
Cyanocobalamin 1000 ug/mL 69680-0112-10 Vitruvias 10 vials $2.909 AP Availability likely
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/mLthis 70069-0171-05 Somerset 5 vials AP FDA listed
Cyanocobalamin 1000 ug/mL 70756-0635-10 Lifestar 10 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 71288-0300-92 Meitheal 25 vials 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
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials70069-0171-10 4,623 Rx · $25,560
Drug total (last 4 qtrs): 4,623 Rx · 10,853 units · $25,560 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cyanocobalamin — the ingredient across all brands.

Top reported reactions

Fatigue3,429
Nausea2,832
Headache2,445
Pain2,324
Diarrhoea2,292
Dyspnoea2,190
Vomiting1,857

Age at onset

Neonate10
Infant7
Child18
Adolescent36
Adult3,397
Elderly3,703

Reporter sex

34,374 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization13,775
Death3,418
Disabling1,753
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,306 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70069-0171-05 You're viewing this 5 VIAL in 1 CARTON (70069-171-05) / 30 mL in 1 VIAL 2018-12-18 Active
70069-0171-10 10 VIAL in 1 CARTON (70069-171-10) / 30 mL in 1 VIAL $0.3281 / mL $98.42 2018-12-18 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 70069-0171-05?
NDC 70069-0171-05 is listed by the FDA — 5 vial in 1 carton / 30 ml in 1 vial.
What NDC number is used to bill for this package of CYANOCOBALAMIN 1000 ug/mL Injection, Solution?
Bill NDC 70069-0171-05 — the 11-digit billing format is 70069017105. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70069-171-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70069-0171-05, written without dashes as 70069017105. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70069-0171-05, the first segment (70069) is the labeler code FDA assigned to Somerset Therapeutics, LLC; the middle segment (0171) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Somerset Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (70069-0171-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Somerset Therapeutics, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 157 words

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, USP is also suitable for the vitamin B 12 absorption test (Schilling test).

⏱️ Dosage and Administration 218 words

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 1000 mcg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications 193 words

CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B 12 is a contraindication. 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, USP 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.

⚠️ Warnings 182 words

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, USP 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 50 words

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 Feeling of swelling of entire body

🆘 Overdosage 9 words

OVERDOSAGE No overdosage has been reported with this drug.

🧬 Clinical Pharmacology ~2 min read

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 1000 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 83 words

HOW SUPPLIED Cyanocobalamin Injection, USP 1000 mcg/mL NDC Number Cyanocobalamin mcg/mL Volume 70069- 171 -05 1,000 30 mL 70069- 171 -10 30 mL vials are Multiple Dose Vials, packaged as; - 5 vials per tray and - 10 vials per tray. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. PROTECT THE PRODUCT FROM LIGHT.

For Product Inquiry call 1-800-417-9175. Revised: April, 2025 Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Made in India Code No.:KR/DRUGS/KTK/28/289/97 ST-CYC13/P/02 1201237

📋 Description 132 words

DESCRIPTION Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%.

Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as red crystalline or small crystals.

It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. 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. Molecular Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.