SODIUM BICARBONATE 84 mg/mL
SODIUM BICARBONATE · INJECTION, SOLUTION · Anthea Pharma Private Limited
SODIUM BICARBONATE is a injection, solution containing sodium bicarbonate at 84 mg/mL, taken intravenous. Manufactured by Anthea Pharma Private Limited.
Key Facts
- Brand Name
- SODIUM BICARBONATE
- Generic Name
- SODIUM BICARBONATE
- NDC Code (Product)
83854-001- Manufacturer
- Anthea Pharma Private Limited
- Strength
- 84 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA219701
- Marketing Start
- 06/26/2025
Recall History
Sage Products Inc
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Olympia Compounding Pharmacy dba Olympia Pharmacy
Lack of assurance of sterility.
Church & Dwight Inc
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Exela Pharma Sciences LLC
Lack of Assurance of Sterility
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
Sage Products Inc
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
SCA Pharmaceuticals
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Bayer HealthCare Pharmaceuticals, Inc.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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…
Dosage & Administration
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 vials (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 s…
Warnings
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 .
Contraindications
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.
Drug Interactions
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.
Adverse Reactions
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.
Frequently Asked Questions
What is SODIUM BICARBONATE used for?
SODIUM BICARBONATE contains SODIUM BICARBONATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is SODIUM BICARBONATE a controlled substance?
SODIUM BICARBONATE is not classified as a controlled substance by the DEA.
What is the generic name for SODIUM BICARBONATE?
The generic name for SODIUM BICARBONATE is SODIUM BICARBONATE. There are 12 other brand versions of SODIUM BICARBONATE.
What is the NDC code for SODIUM BICARBONATE 84 mg/mL?
The NDC (National Drug Code) for SODIUM BICARBONATE 84 mg/mL is 83854-001, listed by Anthea Pharma Private Limited.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)