Sodium acetate anhydrous
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 acetate anhydrous
- Generic name
- SODIUM ACETATE ANHYDROUS
- Manufacturer
- Somerset Therapeutics, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 93edebd6-ef7f-483a-80b6-bfaf34ea5ded
- SPL ID
- 1aae3237-9555-442b-b962-619d23f7e00a
- Version
- 4
- Effective date
- 2025-10-21
- Source export date
- 2026-09-28
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:41:21
| 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 | 219826 | derived:openfda.application_number |
| application number | ANDA219826 | openfda.application_number | |
| brand name | Sodium acetate anhydrous | openfda.brand_name | |
| generic name | SODIUM ACETATE ANHYDROUS | openfda.generic_name | |
| manufacturer name | Somerset Therapeutics, LLC | openfda.manufacturer_name | |
| ndc | package | 70069-047-25 | openfda.package_ndc |
| ndc | package | 70069-048-20 | openfda.package_ndc |
| ndc | product | 70069-048 | openfda.product_ndc |
| ndc | product | 70069-047 | openfda.product_ndc |
| ndc11 | package | 70069004725 | derived:openfda.package_ndc |
| ndc11 | package | 70069004820 | derived:openfda.package_ndc |
| rxcui | 237371 | openfda.rxcui | |
| spl id | 1aae3237-9555-442b-b962-619d23f7e00a | id | |
| spl set id | 93edebd6-ef7f-483a-80b6-bfaf34ea5ded | set_id | |
| unii | NVG71ZZ7P0 | openfda.unii |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Pharmacy Bulk Package. Not for Direct Infusion
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS Sodium acetate injection (2 mEq/mL) must be diluted before use. To avoid sodium overload and water retention, infuse sodium-containing solutions slowly. 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. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (See WARNINGS and PRECAUTIONS ).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.