Prescription drug · ANDA
potassium chloride NDC 72603-338
Potassium chloride 1500 mg/1 · Tablet, Extended release · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-338-01 | 72603033801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72603-338-01)Marketed from Jun 21, 2019 |
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 chloride
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 1500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214422
- Marketing start
- Marketing end
- 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 72603-338_fdab4887-b1a0-49d9-8bf4-07fd86ec6552SPL ID fdab4887-b1a0-49d9-8bf4-07fd86ec6552SPL set ID b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51aRxCUI 1801294, 1801298UNII 660YQ98I10UPC 0372603337013
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472603033801followed by a unit qualifier and the quantityPackage 72603-0338-01. 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 BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to h…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214422
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 Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7616 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-135 |
| potassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-337 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-632 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-133 |
| Potassium Chloride | Potassium chloride 1125 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-134 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-194 |
| Potassium Chloride | Potassium chloride 1125 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-195 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-196 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6253 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2045 |