Prescription drug · ANDA
Sodium Acetate NDC 80830-2435
Sodium acetate anhydrous 164 mg/mL · Injection, Solution, Concentrate · Intravenous · Amneal Pharmaceuticals Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80830-2435-2 | 80830243502 | 25 BOTTLE, PLASTIC in 1 CARTON (80830-2435-2) / 20 mL in 1 BOTTLE, PLASTIC (80830-2435-1)Marketed from Mar 3, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sodium Acetate
- Generic name (nonproprietary)
- sodium acetate
- Active ingredients
- Sodium acetate anhydrous — 164 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218469
- Marketing start
- Listing expires
- Identifiers
- Product ID 80830-2435_0006a5e7-aedf-40a7-9d69-c290ec63ffaaSPL ID 0006a5e7-aedf-40a7-9d69-c290ec63ffaaSPL set ID 0c0b11da-d7fc-4b4c-b0ef-d97af8e88abfRxCUI 1859490UNII NVG71ZZ7P0
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N480830243502followed by a unit qualifier and the quantityPackage 80830-2435-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Sodium acetate injection, 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218469
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | Injection, Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2437 |
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | Injection, Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2436 |