Prescription drug · ANDA
Potassium Phosphates NDC 80830-1693
potassium phosphate, monobasic potassium phosphate, dibasic injection, · Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL · Solution, Concentrate · Intravenous · Amneal Pharmaceuticals Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80830-1693-3 | 80830169303 | 5 VIAL, SINGLE-DOSE in 1 CARTON (80830-1693-3) / 5 mL in 1 VIAL, SINGLE-DOSE (80830-1693-1)Marketed from Oct 23, 2023 | |
| 80830-1693-5 | 80830169305 | 25 VIAL, SINGLE-DOSE in 1 CARTON (80830-1693-5) / 5 mL in 1 VIAL, SINGLE-DOSE (80830-1693-1)Marketed from Oct 23, 2023 |
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)
- Potassium Phosphates
- Generic name (nonproprietary)
- potassium phosphate, monobasic potassium phosphate, dibasic injection,
- Active ingredients
- Potassium phosphate, Monobasic — 224 mg/mLPotassium phosphate, Dibasic — 236 mg/mL
- Dosage form
- Solution, Concentrate
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216344
- 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 80830-1693_d20a884f-9cba-4621-91ee-6e0ba6e361caSPL ID d20a884f-9cba-4621-91ee-6e0ba6e361caSPL set ID 89136c51-a60b-4269-bd05-9489f060a734RxCUI 1928567, 1928569, 1928570UNII 4J9FJ0HL51, CI71S98N1ZUPC 0380830169253
- 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
N480830169303followed by a unit qualifier and the quantityPackage 80830-1693-03. 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 216344
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 injection, | Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL | Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1691 |
| Potassium Phosphatespotassium phosphate, monobasic potassium phosphate, dibasic injection, | Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL | Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1691 |
| Potassium Phosphatespotassium phosphate, monobasic potassium phosphate, dibasic injection, | Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL | Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1691 |
| Potassium Phosphatespotassium phosphate, monobasic potassium phosphate, dibasic injection, | Potassium phosphate, Monobasic 224 mg/mL; Potassium phosphate, Dibasic 236 mg/mL | Solution, ConcentrateIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1692 |