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Cyanocobalamin 1000 ug/mL Injection, 25 vials — NDC 70512-840-25 (Billing 70512-0840-25)

by SOLA Pharmaceuticals · 25 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE

This is a package of 25 vials of Cyanocobalamin 1000 ug/mL Injection from SOLA Pharmaceuticals, marketed since Aug 2022 and currently FDA-listed; retail pharmacies pay about $1.47 per mL (NADAC). It is this product's only package size.

NDC 70512-0840-25
🏷️ FDA NDC (as labeled) 70512-840-25 billing pads the product segment with a zero
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) 70512-840-25
Product NDC 70512-840
11-digit billing NDC 70512084025
NCPDP billing unit ML — per mL (volume)
RxCUI 309594
UNII P6YC3EG204
Application # ANDA215417
SPL Set ID e559c6c8-2973-77fb-e053-2995a90af43d
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 2022-08-03
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form INJECTION
Substance CYANOCOBALAMIN
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 82100010002015
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 1,000 MCG/ML VL
FDB brand name Cyanocobalamin Injection
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002329
  • GCN: 94594
  • GPI-14 (Medi-Span): 82100010002015
  • HICL (First Databank): 001053
  • AHFS class code: 88:08.00.00
  • RxCUI (RxNorm): 309594
Why two NDCs? The FDA registers this code as 70512-840-25 — 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 → 70512-0840-25. 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

Label name CYANOCOBALAMIN 1,000 MCG/ML VL 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 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 mLPer package
Retail pharmacies payNADAC · weekly $1.474 $36.85 / 25 ml
Medicaid paysCMS SDUD · 12 mo $5.52 $138.12 / 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 —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $2.474 $1.474
▼ Down 40% over the last 13 months.
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.

Billing & reimbursement

FDA NDC (as labeled)70512-840-25
11-digit billing NDC70512-0840-25
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3420
DescriptorINJECTION, VITAMIN B-12 CYANOCOBALAMIN, UP TO 1000 MCG
Billing units / pkg1 units
How the units are derivedThis package is 1 ML; the HCPCS unit is 1000 MCG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$219,225 · 343,052 claims · $0.64 per claim (all NDCs under J3420)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70512-0840-25 You're viewing this Main listing 25 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE 2022-08-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 $0.552 AP Availability likely save 63%
Cyanocobalamin 1000 ug/mL 00143-9620-10 Hikma 10 vials $0.739 AP Availability likely save 50%
Cyanocobalamin 1000 ug/mL 69680-0113-99 Vitruvias 10 vials $0.739 AP Availability likely save 50%
cyanocobalamin 1000 ug/mL 70069-0172-10 Somerset 10 vials $0.739 AP Availability likely save 50%
Cyanocobalamin 1000 ug/mL 71288-0301-11 Meitheal 10 vials $0.739 AP Availability likely save 50%
cyanocobalamin 1000 ug/mL 70710-1665-01 Zydus 1 vial $0.761 AP Availability likely save 48%
Cyanocobalamin 1000 ug/mL 00517-0130-01 American 1 vial $0.787 AP Availability likely save 47%
Cyanocobalamin 1000 ug/mL 71288-0302-30 Meitheal 1 vial $0.787 AP Availability likely save 47%
cyanocobalamin 1000 ug/mL 70710-1664-06 Zydus 10 vials $0.819 AP Availability likely save 44%
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/mLthis 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 +1%
Cyanocobalamin 1000 ug/mL 00517-0032-25 American 25 vials $2.134 AP Availability likely +45%
Cyanocobalamin 1000 ug/mL 69680-0112-10 Vitruvias 10 vials $2.970 AP Availability likely +102%
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 70756-0635-10 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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 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

LabelerSOLA Pharmaceuticals
Application holderSOLA PHARMACEUTICALS
FDA applicationANDA215417 (ANDA)
Labeler code70512
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio12 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 154 words ▾

INDICATIONS AND 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 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 (Schilling test).

⏱️ Dosage and Administration 213 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 B12 is the recommended treatment and will be required for the remainder ofthe patient's life.

The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered byintramuscular 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 3weeks.

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 similarto 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 1,000 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 180 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 nervoussystem and bone toxicity. Tissue loading may occur at even lower rates of administration.

🤒 Adverse Reactions 54 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 PHAMRACOLOGY 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 organfor vitamin B12 storage. Within 48 hours after injection of 100 or 1,000 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. Inpeople 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 orother 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 theantianemia factor in purified liver extract. Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.

📦 How Supplied / Storage and Handling 53 words ▾

HOW SUPPLIED Cyanocobalamin Injection, USP 1,000 mcg/mL 70512-840-01 1 mL Multiple-Dose Vial 70512-840-25 Box of 25 Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). PROTECT THE PRODUCT FROM LIGHT. Rev 10/2022 Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA Made in India TN/DRUGS/616/1996 US/LF/047 V01 PLF 169

📋 Description 128 words ▾

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, 0.9%.

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 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. CS

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Precautions : 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 withfolic 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 monthlyinjections of vitamin B12 for the remainder of their lives.

Failure to do so will result in return of the anemia and indevelopment 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 butallow 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 ofvegetarian 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 thefifth 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. Repeatdeterminations 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 carcinogenicpotential 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 donein 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. Pe… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 12 words ▾

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Vial Label Carton Label 25x1mL Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
65.9K
Units reimbursed last 4 qtrs
135.6K
Gross reimbursed last 4 qtrs
$749.4K
Avg / prescription
$11.38
Avg / unit
$5.5248
Latest quarter Q1 2026
13.7KRx
Medicaid pays / mL
$5.5248
gross reimbursed
vs
NADAC / mL
$1.4739
acquisition cost
=
Spread
+$4.0509
+275% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
59% FFS 41% MCO
Fee-for-service · 38,967 Rx Managed care · 26,899 Rx
State Medicaid map
Alaska: 14 units · 1.9 per 100k residents AK Maine: no data reported ME Washington: 287 units · 3.7 per 100k residents WA Idaho: 86 units · 4.4 per 100k residents ID Montana: 39 units · 3.4 per 100k residents MT North Dakota: 31 units · 4.0 per 100k residents ND Minnesota: 1,255 units · 21.9 per 100k residents MN Wisconsin: no data reported WI Michigan: 1,918 units · 19.1 per 100k residents MI New York: 29,489 units · 151 per 100k residents NY Vermont: no data reported VT New Hampshire: 34 units · 2.4 per 100k residents NH Oregon: 207 units · 4.9 per 100k residents OR Nevada: 647 units · 20.3 per 100k residents NV Wyoming: 15 units · 2.6 per 100k residents WY South Dakota: 24 units · 2.6 per 100k residents SD Iowa: 35 units · 1.1 per 100k residents IA Illinois: 784 units · 6.2 per 100k residents IL Indiana: 2,021 units · 29.5 per 100k residents IN Ohio: 2,039 units · 17.3 per 100k residents OH Pennsylvania: 3,952 units · 30.5 per 100k residents PA New Jersey: 2,753 units · 29.6 per 100k residents NJ Massachusetts: 1,089 units · 15.6 per 100k residents MA California: 34,671 units · 89.0 per 100k residents CA Utah: no data reported UT Colorado: 602 units · 10.2 per 100k residents CO Nebraska: 260 units · 13.1 per 100k residents NE Missouri: 929 units · 15.0 per 100k residents MO Kentucky: 5,386 units · 119 per 100k residents KY West Virginia: 2,427 units · 137 per 100k residents WV Virginia: 2,786 units · 32.0 per 100k residents VA Maryland: 1,537 units · 24.9 per 100k residents MD Connecticut: 3,214 units · 88.9 per 100k residents CT Rhode Island: 269 units · 24.6 per 100k residents RI Arizona: 324 units · 4.4 per 100k residents AZ New Mexico: 175 units · 8.3 per 100k residents NM Kansas: 333 units · 11.3 per 100k residents KS Arkansas: 1,531 units · 49.9 per 100k residents AR Tennessee: 471 units · 6.6 per 100k residents TN North Carolina: 4,555 units · 42.0 per 100k residents NC South Carolina: 1,939 units · 36.1 per 100k residents SC Delaware: 90 units · 8.7 per 100k residents DE Oklahoma: no data reported OK Louisiana: 8,734 units · 191 per 100k residents LA Mississippi: 2,570 units · 87.4 per 100k residents MS Alabama: 3,739 units · 73.2 per 100k residents AL Georgia: 5,875 units · 53.3 per 100k residents GA D.C.: 288 units · 42.4 per 100k residents DC Hawaii: no data reported HI Texas: 324 units · 1.1 per 100k residents TX Florida: 5,297 units · 23.4 per 100k residents FL
Units reimbursed · per 100k residents
1.1191
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 191 /100k
2 New York 151 /100k
3 West Virginia 137 /100k
4 Kentucky 119 /100k
5 California 89.0 /100k
6 Connecticut 88.9 /100k
7 Mississippi 87.4 /100k
8 Alabama 73.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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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.