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sodium bicarbonate 12.6 mg/mL Injection, Solution — NDC 00338-0822-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

sodium bicarbonate 12.6 mg/mL Injection, Solution — NDC 0338-0822-10 (Billing 00338-0822-10)

by Baxter Healthcare Corporation · 10 BAG in 1 CARTON / 1000 mL in 1 BAG

This is a package of sodium bicarbonate 12.6 mg/mL Injection, Solution from Baxter Healthcare Corporation, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 00338-0822-10
🏷️ FDA NDC (as labeled) 0338-0822-10 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 10, 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 Sodium Bicarbonate (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 4, 2025 — Lack of Assurance of Sterility. (PFIZER INC) · FDA recall D-0591-2025
Class II · Jul 30, 2025 — Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. (Exela Pharma Sciences LLC) · FDA recall D-0620-2025
Class II · Mar 7, 2025 — Lack of Assurance of Sterility (Exela Pharma Sciences LLC) · FDA recall D-0303-2025
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0234-2024
Class I · Oct 18, 2023 — Presence of Particulate Matter: Silicone (Exela Pharma Sciences LLC) · FDA recall D-0116-2024
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) 0338-0822-10
Product NDC 0338-0822
11-digit billing NDC 00338082210
RxCUI 2747138
UNII 8MDF5V39QO
Application # NDA218524
SPL Set ID b50c858a-00c8-4cb2-ad73-8797f19e656d
Mechanism of action Alkalinizing Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-14
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM BICARBONATE
Quick answers
  • RxCUI (RxNorm): 2747138
Why two NDCs? The FDA registers this code as 0338-0822-10 — a 4-4-2 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 labeler segment → 00338-0822-10. 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.

RxNorm drug class

This medicine belongs to the Salt solutions class.

Drug family (ATC) Salt solutions, Electrolyte solutions
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

📖 What it is MedlinePlus · NLM

Sodium bicarbonate is used to treat metabolic acidosis (when too much acid builds up in your body fluids). Sodium bicarbonate is in a class of medications called alkalinizing agents. It works by providing bicarbonate to balance the effects of acidosis in the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. By mouth, it relieves heartburn, sour stomach and acid indigestion. On the skin, some products ease itching from insect bites and poison ivy. The injecti...
  • Labels for products like Rapidol and De La Cruz Sodium Bicarbonate Antacid say to dissolve it completely in water and drink it. It can be repeated every couple of hours up to a dai...
  • Don't use the maximum dose for more than 2 weeks unless a doctor tells you to. If your symptoms last longer than 2 weeks, stop and see your doctor.
  • Antacids can interact with some prescription drugs. Please check with me or your doctor before using it if you take any.
📖 Read our full Sodium Bicarbonate guide →
4
Nutrient depletion considerations

Sodium Bicarbonate (OTC Drug) may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sodium Bicarbonate (OTC Drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
00338-0822-10 You're viewing this Main listing 10 BAG in 1 CARTON / 1000 mL in 1 BAG 2026-08-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Bicarbonate 12.6 mg/mL 80830-2613-02 Amneal 6 pouches — — FDA listed —
sodium bicarbonate 12.6 mg/mLthis 00338-0822-10 Baxter 1000 ml — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 142M471B3J
    Carbon dioxide is a colorless gas used in medicines as a propellant in pressurized inhalers and aerosol sprays to help deliver the active medication to where it's needed.
  • 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

LabelerBaxter Healthcare Corporation
FDA applicationNDA218524 (NDA)
Labeler code00338
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio283 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. 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 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 181 words ▾

1 INDICATIONS AND USAGE Sodium bicarbonate injection is an alkalinizing agent indicated: • to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. ( 1.1 ) • to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. ( 1.2 ) Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest.

In such situations use a more concentrated solution.

1.1Treatment of Clinically Significant Metabolic Acidosis Sodium bicarbonate injection is indicated to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis.

1.2Urinary Alkalization in Drug Poisoning Sodium bicarbonate injection is indicated to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Sodium bicarbonate injection is administered by intravenous infusion. ( 2.1 ) Do NOT dilute prior to administration. ( 2.1 ) Recommended Dosage in Adults and Pediatric Patients 2 Years of Age and Older Administer 2 mEq/kg to 5 mEq/kg of sodium bicarbonate injection over a four-to eight-hour period, depending upon the severity of metabolic acidosis as assessed by serum bicarbonate concentration, total CO 2 , blood pH and the clinical condition of the patient.

( 2.2 ) Recommended Dosage in Pediatric Patients Less Than 2 Years of Age, including Neonates Administer 1 mEq/kg to 2 mEq/kg of sodium bicarbonate injection over a four-to eight-hour period. Avoid rapid or bolus administration. ( 2.2 )

2.1General Administration Instructions Inspect parenteral drug products for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy or if it contains particulate matter. Discard any unused portion.

Sodium bicarbonate injection is a ready to administer product that requires no further dilution prior to infusion. Administer sodium bicarbonate injection by intravenous infusion, via a dedicated line. Individualize dosage depending on the severity of the acidosis.

Treatment of metabolic acidosis with sodium bicarbonate should be superimposed on measures designed to address the underlying cause of metabolic acidosis.

2.2Recommended Dosage Recommended Dosage in Adults and Pediatric Patients 2 Years of Age and Older Administer 2 mEq/kg to 5 mEq/kg of sodium bicarbonate injection over a four- to eight-hour period, depending upon the severity of metabolic acidosis as assessed by serum bicarbonate concentration, total CO 2 , blood pH and the clinical condition of the patient. Recommended Dosage in Pediatric Patients Less Than 2 Years of Age, including Neonates Administer 1 mEq/kg to 2 mEq/kg of sodium bicarbonate injection over a four- to eight-hour period.

Avoid rapid or bolus administration [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ].

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS Sodium Bicarbonate Injection is a clear, colorless, sterile, nonpyrogenic, isotonic solution intended for intravenous use and available as: Injection: 12.6 mg/mL (0.150 mEq/mL), 12,600 mg of sodium bicarbonate injection in 1,000 mL single-dose Viaflo container Injection: 12.6 mg/mL (0.150 mEq/mL), 12,600 mg of Sodium Bicarbonate Injection in 1,000 mL single-dose Viaflo container. ( 3 )

⛔ Contraindications 63 words ▾

4 CONTRAINDICATIONS Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloremic alkalosis. Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloremic alkalosis. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Edema with Sodium Retention: Monitor patients who are sensitive to sodium intake (heart failure, hypertension, kidney disease, anuria, edema) for signs of fluid overload and adjust as appropriate. ( 5.1 ) • Electrolyte Imbalances: Therapy with sodium bicarbonate injection can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Monitor electrolytes periodically during administration and treat abnormalities appropriately.

Dosing with sodium bicarbonate injection results in a large volume of administration in younger and lighter weight pediatric patients. Consider use of more concentrated sodium bicarbonate formulations in these pediatric populations. ( 5.2 ) • Extravasation: Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site.

( 5.3 )

5.1Edema with Sodium Retention Sodium bicarbonate injection can cause sodium retention and volume overload. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, kidney disease, anuria, edema) for signs of fluid overload and adjust sources of sodium as appropriate.

5.2Electrolyte Imbalances Sodium bicarbonate injection may cause electrolyte imbalances. Overly aggressive therapy with sodium bicarbonate injection can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Monitor electrolytes periodically during administration and treat abnormalities appropriately.

Dosing with sodium bicarbonate injection results in a large volume of administration in younger and lighter weight pediatric patients. Consider use of more concentrated sodium bicarbonate formulations in these pediatric populations [see Dosing and Administration (2) ].

5.3Extravasation Inadvertent extravasation of intravenously administered hypertonic solutions of sodium bicarbonate have been reported to cause chemical cellulitis because of their alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration. Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site of intravenous solution extravasation.

🤒 Adverse Reactions 73 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Edema with Sodium Retention [see Warnings and Precautions (5.1) ] • Electrolyte Imbalances [see Warnings and Precautions (5.2) ] • Extravasation [see Warnings and Precautions (5.3) ] Adverse reactions include edema with sodium retention, electrolyte imbalances and extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pediatric Use: Rapid injection in neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. ( 8.4 )

8.1Pregnancy Risk Summary Available data from published literature over decades of use have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Physiological replacement of sodium bicarbonate is not expected to lead to increased risk of adverse fetal or maternal outcomes. Animal reproduction studies have not been conducted with sodium bicarbonate.

The background risk of major birth defects and miscarriage for the indicated population is 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.

8.2Lactation Risk Summary There are no data on the presence of sodium bicarbonate in either human or animal milk, the effects on the breast-fed infant or the effects on milk production following administration of sodium bicarbonate injection. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sodium bicarbonate injection and any potential adverse effects on the breast-fed child from sodium bicarbonate or from the underlying maternal condition.

8.4Pediatric Use Sodium bicarbonate injection is indicated in pediatric patients: • To raise plasma pH in pediatric patients with clinically significant metabolic acidosis • To alkalinize the urine in drug poisoning in cases in which urinary drug elimination is enhanced by urinary alkalinization Rapid injection of sodium bicarbonate injection solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day.

8.5Geriatric Use Clinical studies of sodium bicarbonate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🤰 Pregnancy 118 words ▾

8.1Pregnancy Risk Summary Available data from published literature over decades of use have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Physiological replacement of sodium bicarbonate is not expected to lead to increased risk of adverse fetal or maternal outcomes. Animal reproduction studies have not been conducted with sodium bicarbonate.

The background risk of major birth defects and miscarriage for the indicated population is 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.

🧒 Pediatric Use 90 words ▾

8.4Pediatric Use Sodium bicarbonate injection is indicated in pediatric patients: • To raise plasma pH in pediatric patients with clinically significant metabolic acidosis • To alkalinize the urine in drug poisoning in cases in which urinary drug elimination is enhanced by urinary alkalinization Rapid injection of sodium bicarbonate injection solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day.

🧓 Geriatric Use 45 words ▾

8.5Geriatric Use Clinical studies of sodium bicarbonate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 58 words ▾

10 OVERDOSAGE If alkalosis results, discontinue the sodium bicarbonate injection and manage the patient according to the degree of alkalosis present. Administer potassium chloride if hypokalemia is present. Treat severe alkalosis accompanied by hyperirritability or tetany with calcium gluconate. In severe alkalosis, consider use of acidifying agent such as ammonium chloride [see Warnings and Precautions (5.2) ] .

🧬 Clinical Pharmacology 183 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH.

12.2Pharmacodynamics Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH.

12.3Pharmacokinetics Distribution Sodium bicarbonate in water dissociates to provide sodium (Na + ) and bicarbonate (HCO 3 - ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid. Bicarbonate (HCO 3 - ) is a normal constituent of body fluids.

Elimination Plasma bicarbonate concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered “labile” since at a proper concentration of hydrogen ion (H + ) it may be converted to carbonic acid (H 2 CO 3 ) and then to its volatile form, carbon dioxide (CO 2 ) excreted by the lung. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH.

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Sodium Bicarbonate Injection, 12.6 mg/mL, is a clear, colorless solution available in 1000 mL Viaflo container closure system. The solution is supplied as following packaging configuration: NDC NUMBER mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO 3 - ) mEq/Container Size (mL) 0338-0822-10 (Carton of 10 bags) 12.6 0.150 0.150 150/1000

16.2Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Do not use unless solution is clear and the container or seal is intact. Discard unused portion.

📋 Description 202 words ▾

11 DESCRIPTION Sodium bicarbonate is an alkalinizing agent. Chemically, it is sodium hydrogen carbonate. Sodium bicarbonate is a white, crystalline powder.

It is soluble in water and insoluble in alcohol. Sodium bicarbonate has the empirical formula NaHCO 3 , a calculated molecular weight of 84.01 and the following structural formula: Sodium Bicarbonate Injection is a sterile, non-pyrogenic, isotonic solution for intravenous infusion. Each mL contains 12.6 mg sodium bicarbonate which is equal to 0.150 milliequivalent each of Na + and HCO 3 - injection.

The pH is adjusted between 7.00 and 9.25 with carbon dioxide. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. Viaflo container is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE).

The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. structural-formula-sodium-bicarbonate-1

💬 Information for Patients 86 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients to report signs and symptoms suggestive of fluid and/or solute overloading, electrolyte imbalances, overhydration, congested states or pulmonary edema [see Warnings and Precautions (5.1) ] . Advise the patient, family or caregiver to report signs of extravasation [see Warnings and Precautions (5.3) ] . Manufactured by: Bieffe Medital SA, Carretera Nacional 260, S/N, Sabiñánigo (Senegüé), Spain (ESP) 22666 Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries.

SA-30-03-157

🧬 Pharmacokinetics 143 words ▾

12.3Pharmacokinetics Distribution Sodium bicarbonate in water dissociates to provide sodium (Na + ) and bicarbonate (HCO 3 - ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid. Bicarbonate (HCO 3 - ) is a normal constituent of body fluids.

Elimination Plasma bicarbonate concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered “labile” since at a proper concentration of hydrogen ion (H + ) it may be converted to carbonic acid (H 2 CO 3 ) and then to its volatile form, carbon dioxide (CO 2 ) excreted by the lung. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.

🧪 Nonclinical Toxicology 23 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, mutagenesis and impairment of fertility studies have not been conducted with sodium bicarbonate.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, mutagenesis and impairment of fertility studies have not been conducted with sodium bicarbonate.

📄 Package Label / Principal Display Panel 175 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0338- 0822 -10 Rx only Sodium Bicarbonate Injection 150 mEq/1,000 mL (0.150 mEq/mL) 1,000 mL For Intravenous Infusion Only No further dilution is necessary. Single-Dose Only - Discard unused portion. Each mL contains sodium bicarbonate USP, 12.6 mg injection.

0.3mOsmol/g (calc.). pH 7.00 to 9.25. Recommended Dosage: see Prescribing Information. Sterile, nonpyrogenic.

Contains no bacteriostat. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. LEAVE BAG IN OVERWRAP UNTIL USE.

After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Viaflo container is not made with natural rubber latex, DEHP, or PVC.

Baxter Logo Manufactured by : Bieffe Medital SA, Carretera Nacional 260 , S / N , Sabiñánigo ( Senegüé ), Spain ( ESP ) 22666 Manufactured for : Baxter Healthcare Corporation Deerfield , IL 60015 USA Baxter and Viaflo are trademarks of Baxter International Inc . or its subsidiaries . UE1974 UN-35-04-739 Do not use this Port Lot EXP: bag-label-2

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Bicarbonate — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Bicarbonate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$136.8K
Claims incl. refills
2.2K
Beneficiaries
722
Spend / beneficiary
$189.50
Spend / claim
$61.05
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 — 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) — 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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
← 00338-0811-04 · Baxter 00338-1005-02 · Baxter →
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.