HomeNDC LookupIngredientsSodium Bicarbonate › 51662-1400-01
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SODIUM BICARBONATE 42 mg/mL Injection, Solution, 5 mL

by HF Acquisition Co LLC, DBA HealthFirst · 5 mL in 1 VIAL, SINGLE-DOSE (51662-1400-1)
NDC 51662-1400-01
🏷️ FDA NDC (as labeled) 51662-1400-1 billing pads the package segment with a zero
Rx only 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 →
⚠️
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) 51662-1400-1
Product NDC 51662-1400
11-digit billing NDC 51662140001
RxCUI 1868469
UNII 8MDF5V39QO
UPC 0363323083052
SPL Set ID 9545d58c-1c49-79b3-e053-2995a90a9d40
Mechanism of action Alkalinizing Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-19
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM BICARBONATE
Why two NDCs? The FDA registers this code as 51662-1400-1 — 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 → 51662-1400-01. 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.

🏭 Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Labeler code51662
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio333 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.

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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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.
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 42 mg/mL 00404-9951-05 Henry 1 vial AP FDA listed
Sodium Bicarbonate 42 mg/mL 00409-5555-01 Hospira, 25 vials AP FDA listed
Sodium Bicarbonate 42 mg/mLthis 51662-1400-01 HF 5 ml FDA listed
Sodium Bicarbonate 42 mg/mL 51662-1497-01 HF 5 ml AP FDA listed
Sodium Bicarbonate 42 mg/mL 63323-0083-05 Fresenius 25 vials AP FDA listed
Sodium Bicarbonate 42 mg/mL 51754-5012-04 Exela 25 vials AP FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

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

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

📊 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
51662-1400-01 You're viewing this 5 mL in 1 VIAL, SINGLE-DOSE (51662-1400-1) 2019-10-19 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 51662-1400-1, 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: 51662-1400-01, written without dashes as 51662140001. 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 51662-1400-01, the first segment (51662) is the labeler code FDA assigned to HF Acquisition Co LLC, DBA HealthFirst; the middle segment (1400) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst 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 209 words

INDICATIONS & 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 blood pigments.

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 CO2 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 & ADMINISTRATION Sodium Bicarbonate Injection, USP is administered by the intravenous route. In cardiac arrest, a rapid intravenous dose of 200 to 300 mEq of bicarbonate, given as a 4.2% or 8.4% solution is suggested for adults. Cautions 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 infants (up to two years of age), intravenous administration at a dose not to exceed 8 mEq/kg/day is recommended.

Slow administration rates and a solution of 4.2% are recommended in neonates, to guard against the possibility of producing hypernatremia, decreasing cerebrospinal fluid pressure and inducing intracranial hemorrhage. 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 CO2 content, blood pH and clinical condition of the patient.

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 acidbase 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 CO2 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 CO2 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 CO2 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 . Do not use unless solution is clear and the container or seal is intact. Discard unused portion.

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 78 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 prevent sloughing of extravasated IV infusions.

🆘 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 181 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 (H2C03) and thence to its volatile form, carbon dioxide (CO2) 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% excreted in the urine.

📦 How Supplied / Storage and Handling 87 words

HOW SUPPLIED/STORAGE AND HANDLING SODIUM BICARBONATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1400-1 SODIUM BICARBONATE INJECTION, USP, 4.2% 2.5mEq (0.5mEq per mL) 5mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. For Product Inquiry: 1-800-551-7176 or www.fresenius-kabi.us 451554 Issued: June 2017 HOW SUPPLIED - STORAGE AND HANDLING LOGO

📋 Description 133 words

DESCRIPTION Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of Sodium Bicarbonate (NaHCO3), USP, in Water for Injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. pH of the solution is 7.0 to 8.5. Solutions are offered in concentrations of 4.2% and 8.4%. See table in HOW SUPPLIED/STORAGE AND HANDLING section for contents and characteristics.

The solutions contain no bacteriostat, antimicrobial agent or added buffer and are 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 NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.

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