Prescription drug · ANDA
Potassium Chloride for Oral Solution NDC 54288-125
Potassium chloride 1.5 g/1.58g · Powder, For solution · Oral · BPI Labs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-125-10 | 5428801251054288012510 | 100 POUCH in 1 CARTON (54288-125-10) / 1.58 g in 1 POUCH (54288-125-01)Marketed from Oct 21, 2019 | |
| 54288-125-30 | 5428801253054288012530 | 30 POUCH in 1 CARTON (54288-125-30) / 1.58 g in 1 POUCH (54288-125-01)Marketed from Oct 21, 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 for Oral Solution
- Generic name (nonproprietary)
- potassium chloride for oral solution
- Active ingredients
- Potassium chloride — 1.5 g/1.58g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- BPI Labs LLCNDC labeler code 54288
- 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 54288-125_3f059da8-fc8c-4f34-9aa6-f86234957975SPL ID 3f059da8-fc8c-4f34-9aa6-f86234957975SPL set ID 1ea4345e-f8bb-4d41-9003-c87b21169d7cRxCUI 1867544UNII 660YQ98I10UPC 0354288125307, 0354288125109
- 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
N454288012510followed by a unit qualifier and the quantityPackage 54288-0125-10. 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 is 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 is insufficient. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 54288-125
- What is NDC 54288-125?
- 54288-125 is the product NDC for Potassium Chloride for Oral Solution, Potassium chloride 1.5 g/1.58g powder, for solution, listed with the FDA by BPI Labs LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Chloride for Oral Solution.
- What is the active ingredient?
- Potassium chloride.
- Who is the labeler?
- BPI Labs LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Potassium Chloride for Oral Solution?
- 6 other product NDCs are listed under this name. See all Potassium Chloride for Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Potassium Chloride for Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Potassium Chloride for Oral Solution | Potassium chloride 1.5 g/1.58g | Powder, For solutionOral | Marlex Pharmaceuticals, Inc. | 10135-807 | 10135-0807-1310135-0807-15 |
| Potassium Chloride for Oral Solution | Potassium chloride 1.5 g/1.58g | SolutionOral | Marlex Pharmaceuticals Inc | 10135-819 | 10135-0819-08 |
| Potassium Chloride for Oral Solution | Potassium chloride 3 g/4.75g | SolutionOral | Marlex Pharmaceuticals Inc | 10135-820 | 10135-0820-08 |
| Potassium Chloride for Oral Solutionpotassium chloride | Potassium chloride 1.5 g/1.58g | For solutionOral | Somerset Therapeutics, LLC | 70069-823 | 70069-0823-0170069-0823-1070069-0823-30 |
| Potassium Chloride for Oral Solutionpotassium chloride | Potassium chloride 1.5 g/1.58g | For solutionOral | Granules Pharmaceuticals Inc. | 70010-071 | 70010-0071-4170010-0071-4270010-0071-43 |
| Potassium Chloride for Oral Solution | Potassium chloride 1.5 g/1.58g | Powder, For solutionOral | Ajenat Pharmaceuticals LLC | 82983-403 | 82983-0403-1082983-0403-30 |
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 | Marlex Pharmaceuticals, Inc. | 10135-807 |
| Potassium Chloride for Oral Solution | Potassium chloride 1.5 g/1.58g | SolutionOral | Marlex Pharmaceuticals Inc | 10135-819 |
| 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 | Ajenat Pharmaceuticals LLC | 82983-403 |