MANGANESE .1 mg/mL Injection, Solution — NDC 0409-4091-01 (Billing 00409-4091-01)
This is a package of MANGANESE .1 mg/mL Injection, Solution from Hospira, Inc., marketed since Jan 2005 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0409-4091-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0409 labeler · 4091 product · 01 package
- Package marketed since
- Jan 31, 2005
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0409409101 3
- Medicaid fills, this package
- 2,543 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- 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
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $165.22 | $41,304.80 / 250 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00409-4091-01 You're viewing this Main listing | 25 VIAL, PLASTIC in 1 TRAY / 10 mL in 1 VIAL, PLASTIC | 2005-01-31 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Manganese .1 mg/mLthis 00409-4091-01 | Hospira, | 25 vials | — | AP | FDA listed | — |
| Manganese .1 mg/mL 65219-0530-10 | Fresenius | 25 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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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.
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9 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Hospira, Inc. labeler code 00409
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- Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND 5 mg/mL; .0091 mg/mL Injection, Solution NDC 0409-4208-10
- Docetaxel 20 mg/mL Injection, Solution NDC 0409-4235-01
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Manganese 0.1 mg/mL (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 ▾
DOSAGE AND ADMINISTRATION Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/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 ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS Direct intramuscular or intravenous injection of Manganese 0.1 mg/mL (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 ▾
ADVERSE REACTIONS None known.
🤰 Pregnancy ▾
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 ▾
Pediatric Use (See DOSAGE AND ADMINISTRATION section.) Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
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 ▾
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 ▾
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 ▾
HOW SUPPLIED Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Single-dose Plastic Vials. Unit of Sale Concentration NDC 0409-4091-01 Tray of 25 Single-dose plastic vials 1 mg/10 mL (0.1 mg/mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1068-4.0 Revised: 12/2023 Logo
📋 Description ▾
DESCRIPTION Manganese 0.1 mg/mL (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, crystalline compound soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound 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 ▾
PRECAUTIONS General Do not use unless solution is clear and seal is intact. Manganese 0.1 mg/mL (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 0.1 mg/mL (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 0.1 mg/mL (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 ▾
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 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of Manganese 0.1 mg/mL (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 ▾
PRINCIPAL DISPLAY PANEL - 10 mL Vial Label 10 mL Vial NDC 0409-4091-11 MANGANESE 1 mg/10 mL (0.1 mg/mL) Manganese Chloride Inj., USP FOR INTRAVENOUS USE ONLY AFTER DILUTION. Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray 10 mL Single-dose NDC 0409-4091-01 Contains 25 of NDC 0409-4091-11 Rx only Manganese 1 mg/10 mL (0.1 mg/mL) Manganese Chloride Injection, USP CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION. Hospira PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
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| 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) | ✓ Available |