Prescription drug · ANDA
Potassium Acetate NDC 65219-510
Potassium acetate 3.93 g/20mL · Injection, Solution, Concentrate · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-510-20 | 65219051020 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-510-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-510-02)Marketed from Nov 27, 2024 |
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)
- Potassium Acetate
- Generic name (nonproprietary)
- potassium acetate
- Active ingredients
- Potassium acetate — 3.93 g/20mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217515
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
- Identifiers
- Product ID 65219-510_67c83f58-73cd-47d2-8dbc-e0fd8331c6e7SPL ID 67c83f58-73cd-47d2-8dbc-e0fd8331c6e7SPL set ID bf4dc488-d6f3-41f8-ac8d-37b27f25b8dbRxCUI 1871155UNII M911911U02UPC 0365219510024
- Pharmacologic class
- Osmotic Laxative; Potassium Salt
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
N465219051020followed by a unit qualifier and the quantityPackage 65219-0510-20. 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 Potassium Acetate Injection, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia 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 65219-510
- What is NDC 65219-510?
- 65219-510 is the product NDC for Potassium Acetate, Potassium acetate 3.93 g/20mL 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?
- Potassium Acetate.
- What is the active ingredient?
- Potassium acetate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Potassium Acetate?
- 4 other product NDCs are listed under this name. See all Potassium Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Potassium 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) |
|---|---|---|---|---|---|
| Potassium Acetate | Potassium acetate 196 mg/mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 65219-512 | 65219-0512-50 |
| Potassium Acetate | Potassium acetate 200 meq/100mL | InjectionIntravenous | Exela Pharma Sciences, LLC | 51754-2004 | 51754-2004-04 |
| Potassium Acetate | Potassium acetate 3.93 g/20mL | Injection, Solution, ConcentrateIntravenous | Hospira, Inc. | 0409-8183 | 00409-8183-25 |
| Potassium Acetate | Potassium acetate 196.3 mg/mL | Injection, Solution, ConcentrateIntravenous | Hospira, Inc. | 0409-3294 | 00409-3294-51 |
Other NDCs under ANDA 217515
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 |
|---|---|---|---|---|
| Potassium Acetate | Potassium acetate 196 mg/mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 65219-512 |