Selenious Acid 40 ug/mL Injection, Solution
Other active recalls for Selenious Acid (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Selenious Acid 40 ug/mL Injection, Solution is an intravenous injectable product containing selenium, a trace mineral. Selenium is typically used in intravenous nutrition formulations to support normal body functions and is commonly included in total parenteral nutrition (TPN) and other IV feeding regimens. This product is an unapproved drug marketed without an FDA-approved application.
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🧪 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.
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UNII 411VRN1TV4
Nitric acid is a strong chemical used in small amounts during drug manufacturing to adjust and maintain the proper acid-base balance of a medicine, ensuring stability and correct formulation.
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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.
2 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 | $16.90 | $845.04 / 50 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Selenious Acid 40 ug/mLthis 81279-0106-05 | Pangea | 5 vials | — | — | FDA listed | — |
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⏳ Availability & generic status
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 81279-0106-05 You're viewing this | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (81279-106-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (81279-106-01) | 2024-05-20 | Active |
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
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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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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 |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Selenium Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Selenium Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day.
In adults, selenium deficiency states resulting from long-term TPN support, selenium as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity. Aseptic addition of Selenium Injection to parenteral nutrition solutions under laminar flow hood is recommended. Selenium is physically compatible with the electrolytes and other trace elements usually present in parenteral nutrition formulations.
Frequent monitoring of plasma selenium levels is suggested as a guideline for subsequent administration. The normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL. Do not directly mix ascorbic acid injection with selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS Selenium Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
⚠️ Warnings ▾
WARNING Selenium Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with selenium should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma selenium levels during TPN support and close medical supervision is recommended.
Selenium Injection is a hypotonic solution and should be administered in admixtures only. 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 The amount of selenium present in Selenium Injection is small. Symptoms of toxicity from selenium are unlikely to occur at the recommended dosage level. To report SUSPECTED ADVERSE REACTIONS, contact Pangea Pharmaceuticals, LLC at 1-855-892-8224 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C: Selenium at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and well controlled studies in pregnant women. Selenium Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Presence of selenium in placenta and umbilical cord blood has been reported in humans.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Selenium is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism. Prolonged TPN support in humans has resulted in selenium deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with selenium.
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of selenium. The conditions are endemic to geographical areas with low selenium soil content. Dietary supplementation with selenium salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of selenium in different human populations have been found to vary and depend on the selenium content of the food consumed. Results of surveys carried out in some countries are tabulated below: Country Number of Samples SELENIUM (mcg/100mL) (a) Whole Blood Blood Cells Plasma / Serum Canada 254 Adults (37.9 ± 7.8) (23.6 ± 6.0) (14.4 ± 2.9) England 8 (b) 26 - 37 (32) - - Guatemala & Southern USA 10 Adults 9 Children (c) 19 - 28 (22) (23 ± 5) - (36 ± 12) - (15 ± 5) New Zealand (d) 113 Adults (5.4 ± 0.1) (6.6 ± 0.3) (4.3 ± 0.1) Thailand 3 Adults 9 Children (e) 14.4 - 20.2 (12.0 ± 3.6) (f) 17.8 - 35.8 (19.5 ± 8.2) 8.1 - 12.5 (8.3 ± 2.2) USA 210 Adults 15.7 - 25.6 (20.6) - - (a) Mean values with or without standard deviation in parentheses, all other ranges.
(b) Age group unknown. (c) Three children recovered from Kwashiorkor and the other six under treatment for other diseases. (d) Low selenium-content soil area.
(e) Well nourished children, three recovered from Kwashiorkor and the other six under treatment for other diseases. (f) Mean values from seven subjects. Plasma selenium levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
Selenium is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of selenium used in supplementation.
Ancillary routes of elimination are lungs and skin.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Selenium Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental selenium 40 mcg/mL). HOW SUPPLIED NDC NUMBER Pharmacy Bulk Package 5 x 10 mL vials per carton 81279-106-05 Pharmacy Bulk Package 10 mL Single-Use Vial 81279-106-01 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). Manufactured for: Pangea Pharmaceuticals, LLC Brielle, NJ 08730 Rev. 04/2024
📋 Description ▾
DESCRIPTION Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental selenium 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.