Home › NDC Lookup › Ingredients › Manganese › 65219-0530-10
Manganese .1 mg/mL Injection, Solution — NDC 65219-0530-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Manganese .1 mg/mL Injection, Solution — NDC 65219-530-10 (Billing 65219-0530-10)

by Fresenius Kabi USA, LLC · 25 VIAL, PLASTIC in 1 TRAY / 10 mL in 1 VIAL, PLASTIC

This is a package of Manganese .1 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 65219-0530-10
🏷️ FDA NDC (as labeled) 65219-530-10 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

NDC database record

One package, one record: these facts belong to NDC 65219-530-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65219 labeler · 530 product · 10 package
Package marketed since
Nov 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0365219530022
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-530-10
Product NDC 65219-530
11-digit billing NDC 65219053010
NCPDP billing unit ML — per mL (volume)
RxCUI 237521
UNII QQE170PANO
UPC 0365219530022
Application # ANDA217583
SPL Set ID 6feb30f0-8b6e-4729-8618-907baf29a2c7
Established class (EPC) Paramagnetic Contrast Agent
Mechanism of action Magnetic Resonance Contrast Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MANGANESE CHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 79500010102010
GCN Seq No 001696
GCN 05230
HICL code 000756
Ingredient (HICL) Manganese Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3M
Therapeutic class — specific (HIC3) Mineral Replacement, Miscellaneous
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name MANGANESE 1 MG/10 ML VIAL
FDB brand name Manganese Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001696
  • GCN: 05230
  • GPI-14 (Medi-Span): 79500010102010
  • HICL (First Databank): 000756
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 237521
Why two NDCs? The FDA registers this code as 65219-530-10 — 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 → 65219-0530-10. 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.

Clinical

Label name MANGANESE 1 MG/10 ML VIAL Ingredient Manganese Chloride

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 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.
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
65219-0530-10 You're viewing this Main listing 25 VIAL, PLASTIC in 1 TRAY / 10 mL in 1 VIAL, PLASTIC 2025-11-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Manganese .1 mg/mL 00409-4091-01 Hospira, 25 vials — AP FDA listed —
Manganese .1 mg/mLthis 65219-0530-10 Fresenius 25 vials — 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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 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.

4 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA217583 (ANDA)
Labeler code65219
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 65219

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

INDICATIONS AND USAGE Manganese chloride injection, USP is indicated for use in adult patients as a supplement to intravenous solutions given for TPN. Administration helps to maintain manganese serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

⏱️ Dosage and Administration 90 words ▾

DOSAGE AND ADMINISTRATION Manganese chloride injection, USP contains 0.1 mg manganese per mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid at least 100 mL. For the adult receiving TPN, the suggested additive dosage for manganese is 55 mcg/day (0.55 mL/day).

Periodic monitoring of manganese plasma levels is suggested as a guideline for subsequent administration. (see WARNINGS . ) Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (see PRECAUTIONS .)

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~2 min read ▾

WARNINGS Direct intramuscular or intravenous injection of manganese chloride injection, USP is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation. Neurologic Toxicity with Manganese Manganese accumulation in the basal ganglia has been reported in adult and pediatric patients on long-term parenteral nutrition receiving manganese at higher than recommended dosages and in association with cholestatic liver disease. Brain MRI findings and clinical symptoms have also been observed in patients who received manganese at or below the recommended dosage and with normal blood manganese concentrations.

Some adult patients with brain MRI findings reportedly experienced neuropsychiatric symptoms, including changes in mood or memory, seizures and/or parkinsonian-like tremors, dysarthria, mask-face, and halting gait. Some pediatric patients experienced dystonic movements or seizures. Regression of symptoms and MRI findings have occurred over weeks to months following discontinuation of manganese in most patients but have not always completely resolved.

Monitor patients receiving parenteral nutrition solutions containing manganese for neurologic signs and symptoms and routinely measure whole blood manganese concentrations and liver tests. In case of suspected manganese toxicity or new neuropsychiatric manifestations, temporarily discontinue manganese, check manganese whole blood concentrations, and consider brain MRI evaluation. Hepatic Accumulation of Manganese Manganese is primarily eliminated in the bile, and excretion is decreased in patients with cholestasis and/or cirrhosis.

Hepatic accumulation of manganese has been reported in autopsies of patients receiving long-term parenteral nutrition containing manganese at dosages higher than recommended. Patients with cholestasis and/or cirrhosis receiving parenteral nutrition are at increased risk of manganese brain deposition and neurotoxicity. If a patient develops signs or symptoms of hepatobiliary disease during the use of this drug product, obtain manganese whole blood concentrations; consider discontinuing manganese supplementation in these patients until a full clinical evaluation is completed.

Aluminum Toxicity 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 22 words ▾

ADVERSE REACTIONS None known. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 47 words ▾

Pregnancy Animal reproduction studies have not been conducted with manganese chloride. It is also not known whether manganese chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Manganese chloride should be given to a pregnant woman only if clearly indicated.

🧒 Pediatric Use 17 words ▾

Pediatric Use (See DOSAGE AND ADMINISTRATION section.) Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 60 words ▾

Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 76 words ▾

OVERDOSAGE Acute manganese toxicity was reported in adult patients following infusion of manganese more than 10,000-fold the recommended dosage and after use of dialysis fluid contaminated with manganese. Signs and symptoms included skin flushing, acute pancreatitis, elevated whole blood manganese concentrations, and MRI evidence of brain accumulation of manganese. Chronic infusion and oral intake of manganese above recommended dosage have resulted in neuropsychiatric symptoms and MRI evidence of brain accumulation of manganese (see WARNINGS . )

🧬 Clinical Pharmacology 141 words ▾

CLINICAL PHARMACOLOGY Manganese is an essential nutrient which serves as an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN helps prevent development of deficiency symptoms such as nausea and vomiting, weight loss, dermatitis and changes in growth and color of hair. Under conditions of minimal intake, 20 mcg manganese/day is retained.

Manganese is bound to a specific transport protein, transmanganin, a beta-l-globulin. Manganese is widely distributed but concentrates in the mitochondria rich tissues such as brain, kidney, pancreas, and liver. Assays for manganese in whole blood result in concentrations ranging from 6 to 12 mcg/manganese/liter.

Excretion of manganese occurs mainly through the bile, but in the event of obstruction, ancillary excretion routes include pancreatic juice, or return into the lumen of the duodenum, jejunum, or ileum. Urinary excretion of manganese is negligible.

📦 How Supplied / Storage and Handling 78 words ▾

HOW SUPPLIED Manganese chloride injection, USP is supplied in 10 mL single-dose plastic vials. Product Code Unit of Sale Strength (Concentration) Each 530110 NDC 65219-530-10 Unit of 25 1 mg per 10 mL (0.1 mg per mL) NDC 65219-530-02 10 mL Single-Dose Plastic Vial Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451863 /Issued: August 2025 logo black-FK

📋 Description 176 words ▾

DESCRIPTION Manganese chloride injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 0.36 mg manganese chloride, tetrahydrate and 9 mg sodium chloride. The solution contains no bacteriostat, antimicrobial agent or added buffer.

The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.313 mOsmol/mL (calc.). Manganese chloride, USP is chemically designated manganese chloride, tetrahydrate (MnCl 2 • 4H 2 O), a deliquescent, light pink to pink solid soluble in water.

Sodium chloride, USP is chemically designated NaCl, a colorless, cubic crystals, or white crystalline powder freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene.

The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Do not use unless solution is clear and seal is intact. Manganese chloride injection, USP should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Laboratory Tests Serum manganese levels can be measured periodically at the discretion of the healthcare provider. Because of the low serum concentration normally present, samples will usually be analyzed by a reference laboratory. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of manganese chloride injection, USP have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when manganese chloride injection, USP additive is administered to a nursing woman. Pediatric Use (See DOSAGE AND ADMINISTRATION section.) Safety and effectiveness in pediatric patients have not been established.

Pregnancy Animal reproduction studies have not been conducted with manganese chloride. It is also not known whether manganese chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Manganese chloride should be given to a pregnant woman only if clearly indicated.

Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🍼 Nursing Mothers 38 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when manganese chloride injection, USP additive is administered to a nursing woman.

🔒 Drug Abuse and Dependence 6 words ▾

DRUG ABUSE AND DEPENDENCE None known.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 35 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of manganese chloride injection, USP have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

📄 Package Label / Principal Display Panel 89 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Manganese Chloride Injection, USP 10 mL Vial Label NDC 65219-530-02 530110 Manganese Chloride Injection, USP 1 mg per 10 mL (0.1 mg per mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION 10 mL Single-Dose Vial Rx only container-label

PACKAGE LABEL - PRINCIPAL DISPLAY - Manganese Chloride Injection, USP 10 mL Tray Label NDC 65219-530-10 530110 Manganese Chloride Injection, USP 1 mg per 10 mL (0.1 mg per mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION. 25 x 10 mL Single-Dose Vials Rx only carton-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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, 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.
← 65219-0512-50 · Fresenius 65219-0531-10 · Fresenius →
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.