Prescription drug · ANDA
Potassium Chloride NDC 43386-168
Potassium chloride 20 meq/15mL · Solution · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-168-01 | 43386016801 | 473 mL in 1 BOTTLE (43386-168-01)Marketed from Sep 24, 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 — 20 meq/15mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209786
- 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 43386-168_b48fb85d-87f5-0c70-e053-2a95a90a7011SPL ID b48fb85d-87f5-0c70-e053-2a95a90a7011SPL set ID 28c49165-d8c9-443a-b000-953b8e1ec55cRxCUI 312515, 314182UNII 660YQ98I10UPC 0343386169016, 0343386168019
- 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
N443386016801followed by a unit qualifier and the quantityPackage 43386-0168-01. 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 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 are insufficient. Potassium chloride is 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 are insufficient
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209786
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 40 meq/15mL | SolutionOral | Lupin Pharmaceuticals,Inc. | 43386-169 |