Sodium Bicarbonate 12.6 mg/mL Injection, Solution
Other active recalls for Sodium Bicarbonate (different manufacturers) — 5 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Salt solutions class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- Sodium bicarbonate antacids work fast for occasional heartburn, but they're not meant for daily long-term use on your own. Most labels say not to use the maximum dose for more than...
- Can I use this for my heartburn every day?
- The active ingredient is the same — sodium bicarbonate. Products like Arm and Hammer Baking Soda are actually FDA-labeled for both antacid use and skin soaks or compresses for irri...
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Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Bicarbonate (OTC Drug) — tap one for details:
Sodium Bicarbonate (OTC Drug) may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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.
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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.
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.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 | 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. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Bicarbonate 12.6 mg/mLthis 80830-2613-02 | Amneal | 6 pouches | — | — | FDA listed | — |
| sodium bicarbonate 12.6 mg/mL 00338-0822-10 | Baxter | 1000 ml | — | — | FDA listed | — |
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⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 80830-2613-02 You're viewing this | 6 POUCH in 1 CARTON (80830-2613-2) / 1 BAG in 1 POUCH (80830-2613-1) / 1000 mL in 1 BAG | 2026-07-13 | Active |
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sodium bicarbonate injection is an alkalinizing agent indicated: to raise plasma pH in adults 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 adults 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 ▾
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 ▾
3 DOSAGE FORMS AND STRENGTHS Sodium bicarbonate injection, USP is a sterile, nonpyrogenic, clear, colorless solution available as: Injection: 150 mEq/1,000 mL (0.15 mEq/mL) in a ready-to-use single-dose infusion bag. Sodium bicarbonate injection USP, 150 mEq/1,000 mL (0.15 mEq/mL) in a single-dose infusion bag. ( 3 )
⛔ Contraindications ▾
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.
⚠️ Warnings and Cautions ▾
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 ▾
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 Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Rapid injection may result in complications of central nervous system related to electrolyte imbalances in pediatric patients less than two years of age. ( 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 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 may result in complications of the central nervous system related to electrolyte imbalances in pediatric patients less than two years of age [see Dosing and Administration (2) and Warnings and Precautions (5.2) ].
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 ▾
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 ▾
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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Sodium bicarbonate injection USP, 150 mEq/1,000 mL (0.15 mEq/mL) is supplied as a sterile, nonpyrogenic, clear, colorless solution available in a ready-to-use infusion bag in the following dosage form: Unit of Sale Unit of Use Conc % mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO 3 - ) mEq/Container size (mL) mOsmol NDC 80830-2613-2 Carton containing 6 Pouch NDC 80830-2613-1 1,000 mL Single-dose Infusion Bag in a Pouch 1.26 12.6 0.15 0.15 150/1,000 0.3/mL
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.
Keep covered in the pouch until time of use. Each ready-to-use infusion bag contains no preservatives. Once the ready-to-use infusion bag has been removed from the pouch, the ready-to-use infusion bag should be used within 24 hours, with any unused portion discarded.
📋 Description ▾
11 DESCRIPTION Sodium bicarbonate injection, USP is an alkalinizing agent, supplied as a sterile, nonpyrogenic, clear, colorless, ready-to-use solution of sodium bicarbonate (NaHCO 3 ) in water for injection for administration by the intravenous infusion as an electrolyte replenisher and systemic alkalizer. Sodium bicarbonate, 12.6 mg is equal to 0.15 milliequivalent each of Na + and HCO 3 - . Sodium bicarbonate, USP is chemically designated NaHCO 3 , molecular weight 84.01 g/mol, a white crystalline powder soluble in water and insoluble in ethanol.
Solution is offered in concentration of 1.26% [see How Supplied Storage and Handling (16.1) ]. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as an intravenous infusion. Carbon dioxide is added to adjust pH between 7 to 8.5.
When smaller doses are required, the unused portion should be discarded.
💬 Information for Patients ▾
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: Amneal Pharmaceuticals Pvt.
Ltd. Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2026-04