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SODIUM BICARBONATE 84 mg/mL Injection, Solution — NDC 83854-0001-20 package photo

SODIUM BICARBONATE 84 mg/mL Injection, Solution

by Anthea Pharma Private Limited · 20 VIAL in 1 CARTON (83854-001-20) / 50 mL in 1 VIAL
NDC 83854-0001-20
🏷️ FDA NDC (as labeled) 83854-001-20 billing pads the product segment with a zero
This package
Contains50 mL in 1 vial Pack sizes2 compare ↓
Also comes in: 25 vials 83854-0001-25
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for 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

FDA NDC (as labeled) 83854-001-20
Product NDC 83854-001
11-digit billing NDC 83854000120
RxCUI 1868486
UNII 8MDF5V39QO
UPC 0383854001011
Application # ANDA219701
SPL Set ID 0df8cf62-4b49-4ec4-aae4-c4a3e6d76549
Mechanism of action Alkalinizing Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM BICARBONATE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 83854-001-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83854-0001-20. 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.

🏭 Manufacturer & labeler

LabelerAnthea Pharma Private Limited
Application holderANTHEA PHARMA PRIVATE LTD
FDA applicationANDA219701 (ANDA)
Labeler code83854
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio17 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.

🩺 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
  • 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...
  • Is baking soda from the kitchen the same as these antacid products?
📖 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.

🧪 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 N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
  • 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.

3 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.

💲 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.
Try another pack size: 25 vials
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Bicarbonate 84 mg/mL 72572-0740-20 Civica 20 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 81298-7620-03 Long 20 vials $0.154 AP Availability likely —
Sodium Bicarbonate 84 mg/mL 81665-0200-05 OMNIVIUM 20 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 51754-5001-04 Exela 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 63323-0089-50 Fresenius 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 70095-0050-03 Sun 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 00404-9980-50 Henry 1 vial — — 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 —
8.4% Sodium Bicarbonate 84 mg/mL 51662-1256-01 HF 50 ml — — FDA listed —
Sodium Bicarbonate 84 mg/mL 51662-1573-01 HF 50 ml — — FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7247-01 Medical 1 vial — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 71872-7310-01 Medical 1 vial — AP 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 82449-0000-05 Steriscience 20 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mLthis 83854-0001-20 Anthea 20 vials — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 84549-0050-03 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 76329-3352-01 International 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/mL 84549-0352-01 ProPharma 50 ml — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 70518-4158-00 REMEDYREPACK 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 51662-1383-01 HF 1 syringe — AP FDA listed —
Sodium Bicarbonate 84 mg/mL 51662-1255-01 HF 1 syringe — — FDA listed —
Sodium Bicarbonate 84 mg/mL 00409-6637-14 Hospira, 1 syringe — 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sodium Bicarbonate — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury2,258
Renal Failure1,927
Chronic Kidney Disease1,858
Diarrhoea1,666
Nausea1,579
Vomiting1,291
Pain1,204

Age at onset

Neonate66
Infant41
Child132
Adolescent102
Adult2,519
Elderly2,003

Reporter sex

28,069 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization13,189
Death4,590
Life-threatening2,443
Disabling841
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2,153 1,007
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83854-0001-20 You're viewing this 20 VIAL in 1 CARTON (83854-001-20) / 50 mL in 1 VIAL 2025-06-26 Active
83854-0001-25 25 VIAL in 1 CARTON (83854-001-25) / 50 mL in 1 VIAL 2025-06-26 Active

Pack size FAQ

What quantity is in NDC 83854-0001-20?
NDC 83854-0001-20 is listed by the FDA — 20 vial in 1 carton / 50 ml in 1 vial.
What NDC number is used to bill for this package of SODIUM BICARBONATE 84 mg/mL Injection, Solution?
Bill NDC 83854-0001-20 — the 11-digit billing format is 83854000120. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83854-001-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83854-0001-20, written without dashes as 83854000120. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83854-0001-20, the first segment (83854) is the labeler code FDA assigned to Anthea Pharma Private Limited; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Anthea Pharma Private Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 25 vials (83854-0001-25). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Anthea Pharma Private 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.

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📋 Description
🎯 Indications and Usage 30 words ▾

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.

⛔ Contraindications 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 .

⚠️ Warnings ~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 amount of sodium present in the solution. 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 CO 2 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, consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Pregnancy: Teratogenic Effects.

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 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 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.

🤒 Adverse Reactions 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 .

🆘 Overdosage 105 words ▾

HOW SUPPLIED Sodium bicarbonate injection, USP is supplied in the following dosage form: NDC Code: Conc % mg/mL (NaHCO 3 ) mEq/mL (Na+) mEq/mL (HCO3) mEq/ Container size (mL) mOsmol 83854-001-20 (20 vials per carton) 8.4 84 1 1 50/50 2/mL 83854-001-25 (25 vials per carton) 8.4 84 1 1 50/50 2/mL The 50 mL sodium bicarbonate injection vials are supplied as either 20 vials per carton, or 25 vials per carton, with a single package insert. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

🧬 Clinical Pharmacology 212 words ▾

INDICATIONS AND USAGE Sodium bicarbonate injection 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.

📋 Description 197 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 (HCO 3 - ) 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 (HCO 3 - ) is a normal constituent of bodyfluids 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83853-0101-01 · IntraBio 83854-0002-10 · Anthea →
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.