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Sodium Bicarbonate 84 mg/mL Injection — NDC 76329-3352-1 (Billing 76329-3352-01)

by International Medication Systems, Limited · 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE

This is a package of Sodium Bicarbonate 84 mg/mL Injection from International Medication Systems, Limited, marketed since Jun 2000 and currently FDA-listed. It is this product's only package size.

NDC 76329-3352-01
🏷️ FDA NDC (as labeled) 76329-3352-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage ⇄ 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

⚠️
Active FDA shortage. Sodium Bicarbonate Injection is currently reported in shortage by the FDA (Demand increase for the drug). Limited Availability Shortage details →
⚠️
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) 76329-3352-1
Product NDC 76329-3352
11-digit billing NDC 76329335201
NCPDP billing unit ML — per mL (volume)
RxCUI 792582
UNII 8MDF5V39QO
Application # ANDA203449
SPL Set ID 77698221-a01d-4568-a7bc-d3d4e982875d
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-06-01
Route INTRAVENOUS
Dosage form INJECTION
Substance SODIUM BICARBONATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79050020002025
GPI class Sodium Bicarbonate
GCN Seq No 001181
GCN 02752
HICL code 000523
Ingredient (HICL) Sodium Bicarbonate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0K
Therapeutic class — specific (HIC3) Bicarbonate Producing/Containing Agents
AHFS code 40:08.00.00
AHFS class Alkalinizing Agents
FDB label name SODIUM BICARB 8.4% SYRINGE
FDB brand name Sodium Bicarbonate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001181
  • GCN: 02752
  • GPI-14 (Medi-Span): 79050020002025
  • HICL (First Databank): 000523
  • AHFS class code: 40:08.00.00
  • RxCUI (RxNorm): 792582
Why two NDCs? The FDA registers this code as 76329-3352-1 — a 5-4-1 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 package segment → 76329-3352-01. 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

Label name SODIUM BICARB 8.4% SYRINGE Ingredient Sodium Bicarbonate
📗 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1.04 $1.04 / 1 syringe
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
76329-3352-01 You're viewing this Main listing 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE 2000-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Bicarbonate 84 mg/mL 51754-5001-04 Exela 25 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 68462-0951-65 Glenmark 25 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 00409-6625-14 Hospira, 25 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 70095-0050-03 Sun 25 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 51754-8888-04 Exela 25 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 72603-0209-25 NORTHSTAR 25 vials $0.154 AP Discontinued —
Sodium Bicarbonate 84 mg/mL 63323-0089-50 Fresenius 25 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 81665-0200-05 OMNIVIUM 20 vials $0.159 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 72572-0740-20 Civica 20 vials $0.159 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 00409-6637-14 Hospira, 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 51662-1255-01 HF 1 syringe — — FDA listed —
Sodium Bicarbonate 84 mg/mL 51662-1383-01 HF 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 70518-4158-00 REMEDYREPACK 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7097-01 Medical 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7266-01 Medical 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mLthis 76329-3352-01 International 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 84549-0352-01 ProPharma 50 ml — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 51754-5011-04 Exela 25 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7247-01 Medical 1 vial — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 50090-0530-00 A-S 50 ml — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 50090-6813-00 A-S 1 vial — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7310-01 Medical 1 vial — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 83854-0001-20 Anthea 20 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 00404-9980-50 Henry 1 vial — — FDA listed —
Sodium Bicarbonate 84 mg/mL 82449-0000-05 Steriscience 20 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 84549-0050-03 ProPharma 50 ml — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 51662-1573-01 HF 50 ml — — FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7371-01 Medical 1 vial — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7376-01 Medical 1 vial — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 72162-2314-02 Bryant 20 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 80830-2305-02 Amneal 25 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71357-0004-10 Milla 10 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 51754-8020-04 Exela 25 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

🏛️
2000
On the market since
Jun 2000
📍
2026
Currently FDA-listed
26 years 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerInternational Medication Systems, Limited
Application holderINTERNATIONAL MEDICATION SYSTEMS LTD
FDA applicationANDA203449 (ANDA)
Labeler code76329
First marketedJun 2000
Product typeHuman Prescription Drug
Portfolio23 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 213 words ▾

INDICATIONS AND USAGE Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products.

Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.

Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Sodium Bicarbonate Injection, USP is administered by the intravenous route. In cardiac arrest , a rapid intravenous dose of one to two 50 mL syringes (44.6 to 100 mEq) may be given initially and continued at a rate of 50 mL (44.6 to 50 mEq) every 5 to 10 minutes if necessary (as indicated by arterial pH and blood gas monitoring) to reverse the acidosis. Caution should be observed in emergencies where very rapid infusion of large quantities of bicarbonate is indicated.

Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration in the process of correcting the metabolic acidosis. In cardiac arrest, however, the risks from acidosis exceed those of hypernatremia. In less urgent forms of metabolic acidosis, Sodium Bicarbonate Injection, USP may be added to other intravenous fluids.

The amount of bicarbonate to be given to older children and adults over a four-to-eight-hour period is approximately 2 to 5 mEq/kg of body weight – depending upon the severity of the acidosis as judged by the lowering of total CO 2 content, blood pH and clinical condition of the patient. In metabolic acidosis associated with shock, therapy should be monitored by measuring blood gases, plasma osmolarity, arterial blood lactate, hemodynamics and cardiac rhythm. Bicarbonate therapy should always be planned in a stepwise fashion since the degree of response from a given dose is not precisely predictable.

Initially an infusion of 2 to 5 mEq/kg body weight over a period of 4 to 8 hours will produce a measurable improvement in the abnormal acid-base status of the blood. The next step of therapy is dependent upon the clinical response of the patient. If severe symptoms have abated, then the frequency of administration and the size of the dose may be reduced.

In general, it is unwise to attempt full correction of a low total CO 2 content during the first 24 hours of therapy, since this may be accompanied by an unrecognized alkalosis because of a delay in the readjustment of ventilation to normal. Owing to this lag, the achievement of total CO 2 content of about 20 mEq/liter at the end of the first day of therapy will usually be associated with a normal blood pH. Further modification of the acidosis to completely normal values usually occurs in the presence of normal kidney function when and if the cause of the acidosis can be controlled.

Values for total CO 2 which are brought to normal or above normal within the first day of therapy are very likely to be associated with grossly alkaline values for blood pH, with ensuing undesired side effects. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

⛔ Contraindications 31 words ▾

CONTRAINDICATIONS Sodium Bicarbonate Injection, USP 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 86 words ▾

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Extravascular infiltration should be avoided, see ADVERSE REACTIONS .

🤒 Adverse Reactions 82 words ▾

ADVERSE REACTIONS Overly aggressive therapy with Sodium Bicarbonate Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability, and tetany) and hypernatremia. 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 part, warmth and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing from extravasated I.V. solutions.

🔄 Drug Interactions 75 words ▾

Drug Interactions Additives may be incompatible; norepinephrine and dobutamine are incompatible with sodium bicarbonate solution. The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided, except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate/calcium admixtures.

NOTE: Do not use the injection if it contains precipitate. Additives may be incompatible. Consult with pharmacist, if available.

When introducing additives, use aseptic technique, mix thoroughly and do not store.

🤰 Pregnancy 52 words ▾

Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 83 words ▾

Pediatric Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate Injection, USP 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. A 4.2% solution may be preferred for such slow administration.

In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed against the potential for fatality due to acidosis.

🧓 Geriatric Use 84 words ▾

Geriatric Clinical studies of Sodium Bicarbonate Injection, USP 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 75 words ▾

OVERDOSAGE Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate.

An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis. See WARNINGS and PRECAUTIONS .

🧬 Clinical Pharmacology 196 words ▾

CLINICAL PHARMACOLOGY Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Sodium bicarbonate in water dissociates to provide sodium (Na + ) and bicarbonate (HCO3¯ ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances.

Bicarbonate (HCO3¯ ) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma 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 thence to its volatile form, carbon dioxide (CO 2 ) excreted by the lung.

Normally a ratio of 1:20 (carbonic acid; bicarbonate) is present in the extracellular fluid. 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 139 words ▾

HOW SUPPLIED Sodium Bicarbonate Injection, USP is supplied in the following dosage form. In 50 mL single-dose packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. 10 individual cartons shrink wrapped as a group of 10 cartons.

Stock No. NDC No. Dosage Form Con. % mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO3 - ) mEq/Contain- er size (mL) mOsm/ mL 3352 76329-3352-1 Prefilled Syringe 8.4% 84 1 1 50/50 2 Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.

Store at 20° to 25°C (68° to 77°F). Excursions allowed between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING. © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2016 SO. EL MONTE, CA 91733, U.S.A.

An Amphastar Pharmaceuticals Company Rev. 1-16 6933520E instructions

📋 Description 154 words ▾

DESCRIPTION Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3 ) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in 8.4% concentration. See table in HOW SUPPLIED section for contents and characteristics.

The solution has an approximate pH of 8.0 (7.5 to 8.5). Carbon dioxide may have been added to adjust the pH of the solution to approximately 8.0. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection.

When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na + and HCO3¯ . Sodium Bicarbonate, USP is chemically designated NaHCO 3 , a white crystalline powder soluble in water.

Water for Injection, USP is chemically designated H 2 O.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Do not use unless solution is clear and the container or seal is intact. Discard unused portion. The potentially large loads of sodium given with bicarbonate require that caution be exercised in the use of sodium bicarbonate in patients with congestive heart failure or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria.

See table in HOW SUPPLIED section for amounts of sodium present in solutions. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Potassium depletion may predispose to metabolic alkalosis and coexistent hypocalcemia may be associated with carpopedal spasm as the plasma pH rises.

These dangers can be minimized if such electrolyte imbalances are appropriately treated prior to or concomitantly with bicarbonate infusion. Laboratory Tests The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO2 content and blood pH, but the risks of overdosage and alkalosis should be avoided. Hence, repeated fractional doses and periodic monitoring by appropriate laboratory tests are recommended to minimize the possibility of overdosage.

Drug Interactions Additives may be incompatible; norepinephrine and dobutamine are incompatible with sodium bicarbonate solution. The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided, except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate/calcium admixtures.

NOTE: Do not use the injection if it contains precipitate. Additives may be incompatible. Consult with pharmacist, if available.

When introducing additives, use aseptic technique, mix thoroughly and do not store. Pregnancy: Teratogenic Effects. Pregnancy Category C.

Animal reproduction studies have not been conducted with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate should be given to a pregnant woman only if clearly needed.

Pediatric Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate Injection, USP 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. A 4.2% solution may be preferred for such slow administration.

In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed against the potential for fatality due to acidosis. Geriatric Clinical studies of Sodium Bicarbonate Injection, USP 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.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPLE DISPLAY PANEL: Carton NDC 76329-3352-1 STOCK NO. 3352 Luer-Lock Prefilled Syringe Rx Only Sodium Bicarbonate Injection USP, 8.4% 50 mEq/50 mL (1 mEq/mL) One 50 mL Single-Dose Prefilled Syringe FOR INTRAVENOUS USE Single Dose. Discard unused portion. LUER-JET™ LUER-LOCK PREFILLED SYRINGE carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2K
Units reimbursed last 4 qtrs
230.5K
Gross reimbursed last 4 qtrs
$239.2K
Avg / prescription
$117.66
Avg / unit
$1.0380
Latest quarter Q4 2025
365Rx
Fee-for-service vs managed care ⓘ
49% FFS 51% MCO
Fee-for-service · 1,002 Rx Managed care · 1,031 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,949 units · 86.3 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 38,111 units · 195 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 1,198 units · 130 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 1,726 units · 13.3 per 100k residents PA New Jersey: 4,059 units · 43.7 per 100k residents NJ Massachusetts: 12 units · 0.2 per 100k residents MA California: 6,649 units · 17.1 per 100k residents CA Utah: 621 units · 18.2 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 9,105 units · 147 per 100k residents MO Kentucky: 1,748 units · 38.6 per 100k residents KY West Virginia: no data reported WV Virginia: 3,698 units · 42.4 per 100k residents VA Maryland: 89,699 units · 1,451 per 100k residents MD Connecticut: 11 units · 0.3 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 16,013 units · 225 per 100k residents TN North Carolina: 40,500 units · 374 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 10,131 units · 250 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 2,230 units · 155 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.21,451
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maryland 1,451 /100k
2 North Carolina 374 /100k
3 Oklahoma 250 /100k
4 Tennessee 225 /100k
5 New York 195 /100k
6 Hawaii 155 /100k
7 Missouri 147 /100k
8 South Dakota 130 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“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 International Medication Systems, Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
International Medication Systems, 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.
← 76329-3340-01 · International 76329-3369-01 · International →
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.