Prescription drug · ANDA
Potassium Chloride for Oral Solution NDC 10135-819
Potassium chloride 1.5 g/1.58g · Solution · Oral · Marlex Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-819-08 | 10135081908 | 1.58 g in 1 BOTTLE (10135-819-08)Marketed from Aug 1, 2025 |
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 for Oral Solution
- Generic name (nonproprietary)
- potassium chloride for oral solution
- Active ingredients
- Potassium chloride — 1.5 g/1.58g
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212183
- 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 10135-819_3e780042-e8cd-95fc-e063-6294a90aa28aSPL ID 3e780042-e8cd-95fc-e063-6294a90aa28aSPL set ID 3e78028d-21a0-ba0f-e063-6294a90aac49RxCUI 312515, 314182UNII 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
N410135081908followed by a unit qualifier and the quantityPackage 10135-0819-08. 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 oral solution is 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 oral solution is 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 212183
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 for Oral Solution | Potassium chloride 1.5 g/1.58g | Powder, For solutionOral | Ajenat Pharmaceuticals LLC | 82983-403 |
| Potassium Chloride for Oral Solution | Potassium chloride 3 g/4.75g | SolutionOral | Marlex Pharmaceuticals Inc | 10135-820 |
| Potassium Chloride for Oral Solution | Potassium chloride 1.5 g/1.58g | Powder, For solutionOral | Marlex Pharmaceuticals, Inc. | 10135-807 |
| Potassium Chloride for Oral Solution | Potassium chloride 1.5 g/1.58g | Powder, For solutionOral | BPI Labs LLC | 54288-125 |