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Selenious Acid 60 ug/mL Injection, Solution — NDC 68083-0660-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Selenious Acid 60 ug/mL Injection, Solution — NDC 68083-660-05 (Billing 68083-0660-05)

by Gland Pharma Limited · 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

This is a package of Selenious Acid 60 ug/mL Injection, Solution from Gland Pharma Limited, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 68083-0660-05
🏷️ FDA NDC (as labeled) 68083-660-05 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 Selenious Acid (different manufacturers) — 1 · 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-0798-2026
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) 68083-660-05
Product NDC 68083-660
11-digit billing NDC 68083066005
RxCUI 2176324
UNII H6241UJ22B
Application # ANDA219629
SPL Set ID 1be55144-afc8-45ff-82a9-162a6279d2a8
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-08
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SELENIUM
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 2176324
Why two NDCs? The FDA registers this code as 68083-660-05 — 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 → 68083-0660-05. 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

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
68083-0660-05 You're viewing this Main listing 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2025-07-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Selenious Acid 60 ug/mL 00517-6560-05 American 5 vials — AP FDA listed —
Selenious Acid 60 ug/mLthis 68083-0660-05 Gland 5 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
Jul 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 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.
  • 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.

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

LabelerGland Pharma Limited
Application holderGLAND PHARMA LTD
FDA applicationANDA219629 (ANDA)
Labeler code68083
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio263 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 65 words ▾

1 INDICATIONS AND USAGE Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package : Not for direct intravenous infusion . ( 2.1 ) • See full prescribing information for information on preparation, administration, and general dosing considerations. ( 2.1 , 2.2, 2.3 , 2.4 , 2.5 ) Recommended Dosage ( 2.5 ) • Selenious Acid Injection provides 60 mcg/mL of selenium. • Individualize the dosage based upon the patient’s clinical condition, nutritional requirements, and the contribution of oral or enteral selenium intake.

The following dosages are general recommendations intended for most patients. However, based upon clinical requirements, some patients may require a higher dosage: o Adults : 60 mcg/day Pediatric Patients 7 kg and above : 2 mcg/kg/day (up to 60 mcg/day) o Pediatric Patients less than 7 kg : 2 to 4 mcg/kg/day • Monitor selenium concentrations during treatment.

2.1Important Administration Information Selenious Acid Injection is supplied as a pharmacy bulk package for admixing use only. It is not for direct intravenous infusion . Prior to administration, Selenious Acid Injection must be transferred to a separate parenteral nutrition container, prepared and used as an admixture in parenteral nutrition solutions.

The Pharmacy Bulk Package vial of Selenious Acid Injection is intended for dispensing of single doses to multiple patients in a pharmacy admixture program. The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.

Solutions with osmolarity of 900 mOsmol/L or greater must be infused through a central venous catheter [see Warnings and Precautions ( 5.2 )].

2.2Preparation and Administration Instructions • Selenious Acid Injection is not for direct intravenous infusion. Prior to administration, Selenious Acid Injection must be prepared and used as an admixture in parenteral nutrition solutions . • Selenious Acid Injection is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. • Visually inspect the prepared parenteral nutrition solution containing Selenious Acid Injection for particulate matter before admixing, after admixing, and prior to administration.

2.3Preparation Instructions for Admixing Using a Parenteral Nutrition Container • Inspect Selenious Acid Injection vials for particulate matter. • Transfer Selenious Acid Injection to the parenteral nutrition solution following the admixture of amino acids, dextrose, lipid (if added), and electrolytes solutions. • Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. Questions about compatibility may be directed to Gland Pharma.

If it is deemed advisable to introduce additives to the parenteral nutrition container, use aseptic technique. • Inspect the final parenteral nutrition solution containing Selenious Acid Injection to ensure that: o Precipitates have not formed during mixing or addition of additives. o The admixed emulsion has not separated, if a lipid emulsion has been added. Separation of the admixed emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets. • Discard if any precipitates are observed.

Stability and Storage • Pharmacy Bulk Package vial (10 mL): Penetrate vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.Use Selenious Acid Injection for admixing promptly once the sterile transfer set has been inserted into the Pharmacy Bulk Package container or not more than 4 hours at room temperature (25ºC/77ºF) after the container closure… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Selenious Acid Injection, USP is a clear colorless solution available in the following: • Pharmacy Bulk Package: 600 mcg/10 mL (60 mcg/mL) of selenium Selenious Acid Injection, USP: ( 3 ) • Pharmacy Bulk Package: 600 mcg/10 mL (60 mcg/mL) of selenium

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Vein Damage and Thrombosi s: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central venous catheter. ( 2.1 , 5.2 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants.

( 5.3 , 5.4 ) • Monitoring and Laboratory Tests : Monitor selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. ( 5.4 , 2.5 )

5.1Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred.

If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration ( 2.2, 2.3 )], the infusion set and catheter should also periodically be checked for precipitates.

5.2Vein Damage and Thrombosis Selenious Acid Injection has a low pH and must be prepared and used as an admixture in parenteral nutrition solutions. It is not for direct intravenous infusion. In addition, consider the osmolarity of the final parenteral nutrition solution in determining peripheral versus central administration.

Solutions with an osmolarity of 900 mOsmol/L or greater must be infused through a central catheter [see Dosage and Administration ( 2.1 )]. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord.

Remove the catheter as soon as possible, if thrombophlebitis develops.

5.3Aluminum Toxicity Selenious Acid Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Preterm infants are particularly at risk for aluminum toxicity because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which also contain aluminum.

Patients with impaired kidney function, including preterm neonates, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Exposure to aluminum from Selenious Acid Injection is not more than 0.6 mcg/kg/day.

When prescribing Selenious Acid Injection for use in parenteral nutrition containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5 mcg/kg/day [see Use in Specific Populations ( 8.4 )].

5.4Monitoring and Laboratory Tests Monitor selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters during treatment [see Dosage and Administration ( 2.5 )].

🤒 Adverse Reactions 160 words ▾

6 ADVERSE REACTIONS No selenium-related adverse reactions have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range. The following adverse reactions associated with use of other components of parenteral nutrition solutions were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.3 )] No selenium-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range.

To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Administration of the recommended dose of Selenious Acid Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous selenious acid. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including selenium, is associated with adverse pregnancy and fetal outcomes.

Pregnant women have an increased metabolic demand for trace elements, including selenium. Parenteral nutrition with selenium should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

8.2Lactation Risk Summary Selenium is present in human milk. Administration of the approved recommended dose of Selenious Acid Injection in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of selenious acid on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Selenious Acid Injection and any potential adverse effects on the breastfed infant from Selenious Acid Injection or from the underlying maternal condition.

8.4Pediatric Use Selenious Acid Injection is approved for use in the pediatric population, including neonates, as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration ( 2.5 )]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Selenious Acid Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.3 )].

8.5Geriatric Use Reported clinical experience with intravenous selenious acid has not identified a difference in selenium requirements between elderly and younger patients. In general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

🤰 Pregnancy 154 words ▾

8.1Pregnancy Risk Summary Administration of the recommended dose of Selenious Acid Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous selenious acid. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including selenium, is associated with adverse pregnancy and fetal outcomes.

Pregnant women have an increased metabolic demand for trace elements, including selenium. Parenteral nutrition with selenium should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

🧒 Pediatric Use 85 words ▾

8.4Pediatric Use Selenious Acid Injection is approved for use in the pediatric population, including neonates, as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration ( 2.5 )]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Selenious Acid Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.3 )].

🧓 Geriatric Use 49 words ▾

8.5Geriatric Use Reported clinical experience with intravenous selenious acid has not identified a difference in selenium requirements between elderly and younger patients. In general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE There are no known cases of overdosage with intravenous selenious acid in parenteral nutrition. Overdosage has been reported with oral selenium. Available selenium concentrations in these subjects have been reported using various assays and laboratory-based reference ranges over a period of time.

Interpret results in the context of current reported ranges. For oral selenium, the Tolerable Upper Limit (UL) is 400 mcg/day and the No Observed Adverse Effect Level (NOAEL) is 800 mcg/day. The estimated oral bioavailability of selenium is approximately 70%.

Acute Oral Toxicity Effects Serious adverse events and deaths have been reported with acute oral toxicity, however, there is no clear correlation between the amount ingested, signs and symptoms of toxicity, or selenium blood concentrations. With severe toxicity, the most common presenting symptoms within a few hours post-ingestion of oral doses greater than 1 gram/day of selenium are gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), altered mental status, and “garlic” breath odor. Death from circulatory collapse has been reported after oral ingestion of 5 to 10 grams of selenium.

Selenium serum or blood concentrations in fatal cases have been reported in the range of 190 mcg/dL to 3,800 mcg/dL. Mild to moderate intoxication (myalgia, muscle spasms, and irritability) has been reported in patients with selenium serum or blood concentrations in the range of 41 to 750 mcg/dL. Chronic Selenosis Chronic daily exposure to selenium from dietary sources (0.003 to 0.007 grams/day) or oral supplements (0.0016 to 0.25 grams/day) may result in alopecia and nail brittleness.

Other signs include gastrointestinal disturbances, skin rash, garlic breath, fatigue, irritability, and nervous system abnormalities including paresthesia and ataxia. Selenium serum or blood concentrations in patients in China exposed through oral (non-dietary) supplementation were in the range of 32 to 150 mcg/dL. Management There is no known antidote for acute selenium toxicity.

Management of selenium overdosage is supportive care based on presenting signs and symptoms.

🧬 Clinical Pharmacology 90 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Selenious acid is converted in vivo to hydrogen selenide via glutathione-involved electron reductions. Hydrogen selenide acts as a selenium pool to form selenoproteins which include, but are not limited to, glutathione peroxidase, iodothyronine deiodinase, peroxidase and thioredoxins.

12.2Pharmacodynamics Selenious acid exposure-response relationships and the time course of pharmacodynamic responses is unknown.

12.3Pharmacokinetics Distribution In humans 85% of intravenous administered 75 Se-sodium selenite was protein-bound within 4 to 6 hours and 95% by 24 hours. Elimination Selenium is primarily eliminated in urine.

🧬 Mechanism of Action 41 words ▾

12.1Mechanism of Action Selenious acid is converted in vivo to hydrogen selenide via glutathione-involved electron reductions. Hydrogen selenide acts as a selenium pool to form selenoproteins which include, but are not limited to, glutathione peroxidase, iodothyronine deiodinase, peroxidase and thioredoxins.

📦 How Supplied / Storage and Handling 73 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Selenious Acid Injection, USP is a clear, colorless solution available as: • 600 mcg/10 mL (60 mcg/mL) of selenium in a 10 mL pharmacy bulk package. Carton of 5 vials (NDC 68083-660-05). The vial closure for each presentation is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] For storage of admixed solution, see Dosage and Administration (2.3).

📋 Description 127 words ▾

11 DESCRIPTION Selenious Acid Injection, USP is a sterile, non-pyrogenic, clear, colorless solution intended for use as a trace element and additive to intravenous solutions for parenteral nutrition. Each 600 mcg/10 mL Pharmacy Bulk Package vial contains 10 mL of selenious acid solution. None of the presentations contain preservatives.

Each mL of the 60 mcg/mL strength contains 60 mcg of selenium present as 98 mcg of selenious acid, nitric acid for pH adjustment (1.8 to 2.4), and water for injection q.s. Selenious Acid Injection 60 mcg/mL contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 16 mOsmol/L. Selenious acid has a molecular weight of 128.97 g/mol and a formula of H 2 SeO 3 .

The structural formula is: selenious acid structure

💬 Information for Patients 71 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Selenious Acid Injection: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Manufactured by: Gland Pharma Limited Hyderabad-502 307, India ML No: 2/MD/TS/2015/F/G Revised Date: August 2024

🧬 Pharmacokinetics 31 words ▾

12.3Pharmacokinetics Distribution In humans 85% of intravenous administered 75 Se-sodium selenite was protein-bound within 4 to 6 hours and 95% by 24 hours. Elimination Selenium is primarily eliminated in urine.

🧬 Pharmacodynamics 15 words ▾

12.2Pharmacodynamics Selenious acid exposure-response relationships and the time course of pharmacodynamic responses is unknown.

📄 Package Label / Principal Display Panel 86 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 68083- 660 -01 Rx Only Selenious Acid Injection, USP 600 mcg*/10 mL (60 mcg*/mL) of Selenium Pharmacy Bulk Package - Not for Direct Infusion For intravenous use after dilution and admixing PRESERVATIVE FREE 10 mL Carton Label NDC 68083- 660 -05 Rx Only Selenious Acid Injection, USP 600 mcg*/10 mL (60 mcg*/mL) of Selenium Pharmacy Bulk Package - Not for Direct Infusion For intravenous use after dilution and admixing STERILE. PRESERVATIVE FREE 5 x 10 mL Vials selenious-acid-spl-container-label selenious-acid-spl-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 Gland Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gland Pharma Limited 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.
← 68083-0657-10 · Gland 68083-0661-01 · Gland →
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.