Prescription drug · ANDA
Potassium Chloride NDC 65862-986
Potassium chloride 600 mg/1 · Tablet, Film coated, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-986-01 | 65862098601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-986-01)Marketed from Dec 19, 2018 | |
| 65862-986-05 | 65862098605 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-986-05)Marketed from Dec 19, 2018 | |
| 65862-986-12 | 65862098612 | 120 BLISTER PACK in 1 CARTON (65862-986-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-986-06)Marketed from Dec 19, 2018 | |
| 65862-986-80 | 65862098680 | 80 BLISTER PACK in 1 CARTON (65862-986-80) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-986-04)Marketed from Dec 19, 2018 |
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 — 600 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210921
- 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 65862-986_43cc6b36-fcf7-4e43-b66a-00eecc48d0a7SPL ID 43cc6b36-fcf7-4e43-b66a-00eecc48d0a7SPL set ID d43beabe-b801-4319-ad36-9a80856b94bdRxCUI 312529, 628953UNII 660YQ98I10
- 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
N465862098601followed by a unit qualifier and the quantityPackage 65862-0986-01. 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)
Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release tablets are a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210921
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 750 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-2964 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5335 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | BluePoint Laboratories | 68001-518 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7216 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8262 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-1032 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-944 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-987 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 60687-810 |
| Potassium Chloride | Potassium chloride 600 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2620 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-463 |