Prescription drug · ANDA
Potassium Phosphates (potassium phosphate) NDC 0517-2102
Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL · Injection, Solution · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-2102-25 | 00517210225 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2102-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-2102-01)Marketed from Oct 13, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Phosphates
- Generic name (nonproprietary)
- potassium phosphate
- Active ingredients
- Potassium phosphate, Monobasic — 224 mg/mLPotassium phosphate, Dibasic — 236 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- American Regent, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216274
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Potassium Compounds (Chemical structure)
- Identifiers
- Product ID 0517-2102_e76a57d0-94d0-4eed-9969-66f2c553ed5cSPL ID e76a57d0-94d0-4eed-9969-66f2c553ed5cSPL set ID 41a85cca-c463-4f39-9335-177b04c290a9RxCUI 1928567, 1928569, 2667657UNII 4J9FJ0HL51, CI71S98N1Z
- 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
N400517210225followed by a unit qualifier and the quantityPackage 00517-2102-25. 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)
Potassium Phosphates Injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. Potassium Phosphates Injection is a phosphorus replacement product indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. ( 1 ) for parenteral nutrition in adults and pediatric…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216274
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 Phosphatespotassium phosphate, monobasic potassium phosphate, dibasic | Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2505 |
| Potassium Phosphates | Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2051 |