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Prescription medicine · generic available

Sodium bicarbonate

Also sold without a prescription: Sodium bicarbonate (over the counter) →

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
Current shortageFDA shortage list
13Recalls (FDA reports)
22Companies
2016First FDA approval on file

Quick answers

What is Sodium bicarbonate used for?
The FDA-approved label (Sodium Bicarbonate, Baxter Healthcare Corporation, August 14, 2026) says: “Sodium bicarbonate injection is an alkalinizing agent indicated: • to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. • to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sodium bicarbonate have a boxed warning?
No. None of the 36 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Sodium bicarbonate?
The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
Has Sodium bicarbonate been recalled?
FDA enforcement reports list 13 recalls of products of this medicine; the newest started August 4, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Sodium bicarbonate?
22 companies list prescription products of Sodium bicarbonate in the FDA NDC Directory, including Exela Pharma Sciences, LLC, Medical Purchasing Solutions, LLC and Hospira, Inc..

What Sodium bicarbonate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Sodium bicarbonate injection is an alkalinizing agent indicated: • to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. • to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. …

— FDA label: Sodium Bicarbonate, Baxter Healthcare Corporation, effective August 14, 2026. Read the full label on DailyMed →

The FDA has 36 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 36 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection · Solution
RouteIntravenous
Prescription products39 in the FDA NDC Directory

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Sodium bicarbonate, by strength and form
Strength and formGeneric or brandPharmacies pay
sodium bicarbonate 84 mg/mL
injection, solution		 Generic $0.1540–$0.1613 per mL
11 packages, lowest to highest
sodium bicarbonate 84 mg/mL
solution		 Generic $0.1613 per mL

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA218524
SODIUM BICARBONATE		 Baxter Hlthcare CorpAugust 14, 2026 1, latest October 6, 2026
2026: Labeling
NDA220790
SODIUM BICARBONATE		 AmnealJuly 9, 2026 —

Generic approvals (12)

Shortage status

Current shortage · updated October 21, 2026 · first posted March 1, 2017

ProductSodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-35)
AvailabilityUnavailable
Reason givenOther
CompanyHospira, Inc., a Pfizer Company

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. August 4, 2025 · Class II · Ongoing · D-0591-2025

    Lack of Assurance of Sterility.

    Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14. — PFIZER INC

  2. July 30, 2025 · Class II · Ongoing · D-0620-2025

    Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

    4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-50 — Exela Pharma Sciences LLC

  3. March 7, 2025 · Class II · Ongoing · D-0303-2025

    Lack of Assurance of Sterility

    8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: — Exela Pharma Sciences LLC

  4. December 21, 2023 · Class I · Ongoing · D-0234-2024

    Presence of Particulate Matter; identified as glass

    8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-66 — Pfizer Inc.

  5. October 18, 2023 · Class I · Ongoing · D-0116-2024

    Presence of Particulate Matter: Silicone

    8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-50 — Exela Pharma Sciences LLC

  6. November 28, 2022 · Class I · Terminated · D-0079-2023

    Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 5 — Exela Pharma Sciences LLC

  7. November 28, 2022 · Class I · Terminated · D-0080-2023

    Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 286 — Exela Pharma Sciences LLC

  8. October 4, 2022 · Class I · Terminated · D-0023-2023

    Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 286 — Exela Pharma Sciences LLC

  9. October 4, 2022 · Class I · Terminated · D-0022-2023

    Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 5 — Exela Pharma Sciences LLC

  10. January 11, 2022 · Class II · Terminated · D-0369-2022

    Lack of Assurance of Sterility

    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1 — Exela Pharma Sciences LLC

  11. March 15, 2019 · Class I · Terminated · D-1073-2019

    Presence of Particulate Matter; glass particulates

    8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02 — Pfizer Inc.

  12. June 15, 2017 · Class II · Terminated · D-1047-2017

    Lack of Sterility Assurance

    8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02 — Hospira a Pfizer Company

  13. March 18, 2016 · Class I · Ongoing · D-0865-2016

    Presence of Particulate Matter: particulate matter identified as an insect in one vial.

    8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02 — Hospira Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)727995, 792582, 807284, 1868469, 1868486, 1923484, 2198792, 2747138
SPL set ID of the quoted labelb50c858a-00c8-4cb2-ad73-8797f19e656d
FDA labels (SPL)36
FDA applicationsNDA218524, NDA220790, 12 ANDA
Active ingredients (FDA)SODIUM BICARBONATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Sodium Bicarbonate, Baxter Healthcare Corporation, effective August 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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