Sodium Bicarbonate
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Sodium Bicarbonate
- Generic name
- SODIUM BICARBONATE
- Manufacturer
- Civica
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a10fdfbc-94a0-49ab-b26c-de1df042bc89
- SPL ID
- 8fcbd37e-e4d5-4137-9abf-c398fbb5cbf0
- Version
- 3
- Effective date
- 2025-11-24
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:38:03
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 211091 | derived:openfda.application_number |
| application number | ANDA211091 | openfda.application_number | |
| brand name | Sodium Bicarbonate | openfda.brand_name | |
| generic name | SODIUM BICARBONATE | openfda.generic_name | |
| manufacturer name | Civica | openfda.manufacturer_name | |
| ndc | package | 72572-740-25 | openfda.package_ndc |
| ndc | product | 72572-740 | openfda.product_ndc |
| ndc11 | package | 72572074025 | derived:openfda.package_ndc |
| rxcui | 1868486 | openfda.rxcui | |
| spl id | 8fcbd37e-e4d5-4137-9abf-c398fbb5cbf0 | id | |
| spl set id | a10fdfbc-94a0-49ab-b26c-de1df042bc89 | set_id | |
| unii | 8MDF5V39QO | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.