Prescription drug · ANDA
Potassium Chloride Extended-release NDC 68788-8196
Potassium chloride 1500 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8196-3 | 68788819603 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8196-3)Marketed from May 23, 2022 | |
| 68788-8196-6 | 68788819606 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8196-6)Marketed from May 23, 2022 | |
| 68788-8196-9 | 68788819609 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8196-9)Marketed from May 23, 2022 |
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 Chloride Extended-release
- Generic name (nonproprietary)
- potassium chloride extended-release
- 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 214452
- 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 68788-8196_bb1a06ef-f841-4688-97dc-b4cce0a19b06SPL ID bb1a06ef-f841-4688-97dc-b4cce0a19b06SPL set ID 87f369cf-40e5-4f91-aa42-ae986fce6544RxCUI 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
N468788819603followed by a unit qualifier and the quantityPackage 68788-8196-03. 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)
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. 1. 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 t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214452
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 Extended-release | Potassium chloride 750 mg/1 | TabletOral | Granules India Ltd | 62207-726 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | TabletOral | Granules India Ltd | 62207-727 |
| Potassium Chloride ER | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-648 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-135 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-136 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2160 |
| Potassium Chloride Extended-Release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8399 |
| Potassium Chloride Extended-Release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8400 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | TabletOral | Bluepoint Laboratories | 68001-566 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | TabletOral | Bluepoint Laboratories | 68001-567 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1896 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7192 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7193 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2503 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4095 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4383 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-824 |
| Potassium Chloride ER | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-629 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Atlantic Biologicals Corp. | 17856-1135 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-109 |
- openFDA data updated
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