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CYANOCOBALAMIN 1000 ug/mL Injection, 10 pouches — NDC 51662-1394-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CYANOCOBALAMIN 1000 ug/mL Injection, 10 pouches — NDC 51662-1394-3 (Billing 51662-1394-03)

by HF Acquisition Co LLC, DBA HealthFirst · 10 POUCH in 1 CASE / 1 mL in 1 POUCH

This is a package of 10 pouches of CYANOCOBALAMIN 1000 ug/mL Injection from HF Acquisition Co LLC, DBA HealthFirst, marketed since Oct 2019 and currently FDA-listed.

NDC 51662-1394-03
🏷️ FDA NDC (as labeled) 51662-1394-3 billing pads the package segment with a zero
This package
Contains10 pouches Pack sizes2 compare ↓
Product page 51662-1394-01 Also comes in: 30 ml 51662-1394-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1394-3
Product NDC 51662-1394
11-digit billing NDC 51662139403
RxCUI 309594
UNII P6YC3EG204
Application # ANDA080515
SPL Set ID 953aa8c6-31ce-0c3b-e053-2a95a90ab35f
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 2019-10-18
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form INJECTION
Substance CYANOCOBALAMIN
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309594
Why two NDCs? The FDA registers this code as 51662-1394-3 — a 5-4-1 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 package segment → 51662-1394-03. 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.

Clinical

📖 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 replaces vitamin B12 when you are low. Doctors use it for deficiency from poor absorption, pernicious anemia, or a diet low in B12. The injection and the nasal spray are approve...
  • The usual approach is one spray in one nostril once a week. Use it at least an hour before or after hot foods or drinks. Follow your prescriber and your product label.
  • Some injection products are labeled to be given by a healthcare professional and not for self-administration. Ask your prescriber how yours should be given. It should never go into...
  • With the nasal spray, people reported colds, headache, weakness, nausea, a sore tongue, tingling and a runny nose. Call your doctor about anything that bothers you. Get emergency h...
📖 Read our full Cyanocobalamin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 eachPer 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: 30 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1394-01 51662-1394-1 Main listing 30 mL in 1 VIAL, MULTI-DOSE 2019-10-18 — Active
51662-1394-03 You're viewing this 10 POUCH in 1 CASE / 1 mL in 1 POUCH 2021-01-12 — Active

Pack size FAQ

What quantity is in this package?
This package contains 10 pouches — 10 pouch in 1 case / 1 ml in 1 pouch.
How does this package differ from NDC 51662-1394-01?
Both are CYANOCOBALAMIN 1000 ug/mL Injection — the drug itself is identical. This page's package is the 10 pouches one, while NDC 51662-1394-01 is the 30 ml package.
What NDC number is used to bill for this package of CYANOCOBALAMIN 1000 ug/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 $0.552 AP Availability likely —
Cyanocobalamin 1000 ug/mL 00143-9620-10 Hikma 10 vials $0.739 AP Availability likely —
Cyanocobalamin 1000 ug/mL 69680-0113-99 Vitruvias 10 vials $0.739 AP Availability likely —
cyanocobalamin 1000 ug/mL 70069-0172-10 Somerset 10 vials $0.739 AP Availability likely —
Cyanocobalamin 1000 ug/mL 71288-0301-11 Meitheal 10 vials $0.739 AP Availability likely —
cyanocobalamin 1000 ug/mL 70710-1665-01 Zydus 1 vial $0.761 AP Availability likely —
Cyanocobalamin 1000 ug/mL 00517-0130-01 American 1 vial $0.787 AP Availability likely —
Cyanocobalamin 1000 ug/mL 71288-0302-30 Meitheal 1 vial $0.787 AP Availability likely —
cyanocobalamin 1000 ug/mL 70710-1664-06 Zydus 10 vials $0.819 AP Availability likely —
Cyanocobalamin 1000 ug/mL 00143-9621-25 Hikma 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 00517-0031-25 American 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 25021-0502-01 Sagent 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 63323-0044-01 Fresenius 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 68001-0542-60 BluePoint 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 68001-0640-60 BluePoint 25 vials $1.474 AP Availability likely —
cyanocobalamin 1000 ug/mL 70069-0005-10 Somerset 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 70512-0840-25 SOLA 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 71288-0300-92 Meitheal 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 71288-0303-02 Meitheal 25 vials $1.474 AP Availability likely —
Cyanocobalamin 1000 ug/mL 72603-0650-25 NorthStar 25 vials $1.474 AP Availability likely —
cyanocobalamin 1000 ug/mL 70710-1663-07 Zydus 25 vials $1.491 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 $2.970 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/mLthis 51662-1394-03 HF 10 pouches — 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 70756-0635-10 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 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.

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.

  • 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 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 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.

3 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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderWEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
FDA applicationANDA080515 (ANDA)
Labeler code51662
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio333 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 159 words ▾

INDICATIONS & USAGE Cyanocobalamin is indicated for vitamin B12 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 PRECAUTIONS- 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 B12 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 B12 absorption test ( DOSAGE & ADMINISTRATION- Schilling test).

⏱️ Dosage and Administration 216 words ▾

DOSAGE & 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 B12 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 B12 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 10 words ▾

CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B12 is a contraindication.

⚠️ Warnings 181 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 B12 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 B12 (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

🆘 Overdosage 9 words ▾

OVERDOSAGE No overdosage has been reported with this drug.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Vitamin B12 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 B12 is transported via specific B12 binding proteins, transcobalamin I and II to the various tissues.

The liver is the main organ for vitamin B12 storage. Within 48 hours after injection of 100 or 1000 mcg of vitamin B12, 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 B12 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 B12 prevents progression of neurologic damage. The average diet supplies about 5 to 15 mcg/day of vitamin B12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B12 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 B12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B12 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 B12. Cyanocobalamin is the most widely used form of vitamin B12, 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 204 words ▾

HOW SUPPLIED CYANOCOBALAMIN INJECTION is supplied in the following dosage forms NDC 51662-1394-1 CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-2 Pouch containing a single CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-3 Case of 10 pouches - CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Cyanocobalamin Injection, USP 1000 mcg/mL is available in the following packages: NDC 0143-9621-25 1 mL Vial Boxes of 25 Vials NDC 0143-9620-10 10 mL Multiple Dose Vial Boxes of 10 Vials NDC 0143-9619-10 30 mL Multiple Dose Vial Boxes of 10 Vials Storage 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 FROM LIGHT. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised June 2017 PIN350-WES/3

📋 Description 120 words ▾

DESCRIPTION Cyanocobalamin Injection (vitamin B12) is a sterile solution of Cyanocobalamin. Each mL contains Cyanocobalamin 1000 mcg, sodium chloride 9 mg and benzyl alcohol 0.015 mL in water for injection. Hydrochloric acid and/or sodium hydroxide may have been added 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). It is stable to autoclaving for short periods at 121°C.

The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%.

The molecular weight is 1355.39. The structural formula is represented below. STRUCTURE

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result.

Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. Information for Patients Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 for the remainder of their lives.

Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but allow progression of subacute combined degeneration. A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12.

Patients following such a diet, should be advised to take oral vitamin B12 regularly. The need for vitamin B12 is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.

Laboratory Tests During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely the first 48 hours and potassium replaced if necessary. Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy and then frequently until the hematocrit is normal.

If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow.

Patients with pernicious anemia have about 3 times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated. Drug/Laboratory Test Interactions Persons taking most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays. Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.

Pregnancy Teratogenic Effects: Pregnancy Category C Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.

Nursing Mothers Vitamin B12 is known to be excreted in human milk. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women (4 mcg daily) should be consumed during lactation. Pediatric Use Intake… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 38 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL LABELING

PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING SERIALIZED LABELING

Principal Display Panel - 51662-1394-2 - Pouch Labeling Pouch Labeling

Principal Display Panel - 51662-1394-3 - Case Labeling RFID Label Case Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 HF Acquisition Co LLC, DBA HealthFirst. 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 30 ml (51662-1394-01). 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?
HF Acquisition Co LLC, DBA HealthFirst 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.
← 51662-1393-01 · HF 51662-1395-01 · HF →
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.