Prescription drug · ANDA
Sodium Acetate NDC 63323-032
Sodium acetate 4 meq/100mL · Injection, Solution, Concentrate · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-032-00 | 6332300320063323003200 | 20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-032-00) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-032-04)Marketed from Oct 30, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 4 meq/100mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206687
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-032_37c19fc5-c1ce-4ea0-9cba-4cdf32112091SPL ID 37c19fc5-c1ce-4ea0-9cba-4cdf32112091SPL set ID d7fabf08-d4e0-4bb5-8416-2e8ffe27c04bRxCUI 312965UNII 4550K0SC9B
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
N463323003200followed by a unit qualifier and the quantityPackage 63323-0032-00. 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, USP (4 mEq per mL) 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.
About NDC 63323-032
- What is NDC 63323-032?
- 63323-032 is the product NDC for Sodium Acetate, Sodium acetate 4 meq/100mL injection, solution, concentrate, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Acetate.
- What is the active ingredient?
- Sodium acetate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Acetate?
- 12 other product NDCs are listed under this name. See all Sodium Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | Injection, Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2435 | 80830-2435-02 |
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | Injection, Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2436 | 80830-2436-02 |
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | Injection, Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2437 | 80830-2437-02 |
| Sodium Acetate | Sodium acetate 164 mg/mL | Injection, Solution, ConcentrateIntravenous | MILLA PHARMACEUTICALS INC. | 71357-002 | 71357-0002-10 |
| Sodium Acetatesodium acetate injection, usp, 400 meq/100 ml | Sodium acetate 400 meq/100mL | Injection, Solution, ConcentrateIntravenous | MILLA PHARMACEUTICALS INC. | 71357-009 | 71357-0009-10 |
| Sodium Acetate | Sodium acetate 164 mg/mL | Injection, Solution, ConcentrateIntravenous | MILLA PHARMACEUTICALS INC. | 71357-007 | 71357-0007-10 |
| Sodium Acetatesodium acetate injection, usp, 200 meq/100 ml | Sodium acetate 200 meq/100mL | Injection, Solution, ConcentrateIntravenous | MILLA PHARMACEUTICALS INC. | 71357-008 | 71357-0008-10 |
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6261 | 00641-6261-01 |
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6262 | 00641-6262-01 |
| Sodium Acetate | Sodium acetate anhydrous 164 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6263 | 00641-6263-10 |