Prescription drug · ANDA
Potassium Chloride NDC 71610-343
Potassium chloride 1500 mg/1 · Tablet, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-343-15 | 71610034315 | 15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-15)Marketed from Nov 1, 2019 | |
| 71610-343-30 | 71610034330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-30)Marketed from Sep 18, 2019 | |
| 71610-343-45 | 71610034345 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-45)Marketed from Sep 18, 2019 | |
| 71610-343-53 | 71610034353 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-53)Marketed from Sep 18, 2019 | |
| 71610-343-60 | 71610034360 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-60)Marketed from Sep 18, 2019 | |
| 71610-343-70 | 71610034370 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-70)Marketed from May 19, 2026 | |
| 71610-343-73 | 71610034373 | 135 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-73)Marketed from Oct 25, 2019 | |
| 71610-343-80 | 71610034380 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-80)Marketed from Sep 18, 2019 | |
| 71610-343-90 | 71610034390 | 240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-90)Marketed from Oct 9, 2020 | |
| 71610-343-92 | 71610034392 | 270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-343-92)Marketed from Sep 18, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074726
- 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 71610-343_5244d376-6027-2371-e063-6294a90aca2bSPL ID 5244d376-6027-2371-e063-6294a90aca2bSPL set ID d2e84d34-e042-477f-9944-3fcb95301217RxCUI 1801294UNII 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
N471610034315followed by a unit qualifier and the quantityPackage 71610-0343-15. 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 074726
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 | Bryant Ranch Prepack | 71335-1747 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Upsher-SmithLaboratories, LLC | 0832-5324 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Upsher-SmithLaboratories, LLC | 0832-5325 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-027 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-568 |
| Klor-Con Mpotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-5317 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-507 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6867 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6866 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2243 |
| Klor-Con Mpotassium chloride | Potassium chloride 1125 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-5318 |
| Klor-Con Mpotassium chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-5319 |
| Klor-Con Mpotassium chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-5634 |