Prescription drug · ANDA
Potassium Chloride NDC 54288-160
Potassium chloride 20 meq/15mL · Solution · Oral · BPI Labs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-160-47 | 54288016047 | 473 mL in 1 BOTTLE, PLASTIC (54288-160-47)Marketed from Jul 4, 2023 |
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
- BPI Labs LLCNDC labeler code 54288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216156
- 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 54288-160_d5ffd201-1ecb-4326-93fc-cc25b128a71cSPL ID d5ffd201-1ecb-4326-93fc-cc25b128a71cSPL set ID aeb2e14e-cd7c-49d0-a15f-fbbe89a03c6bRxCUI 312515, 314182UNII 660YQ98I10UPC 0354288160476
- 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
N454288016047followed by a unit qualifier and the quantityPackage 54288-0160-47. 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 are 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 are insufficient. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 54288-160
- What is NDC 54288-160?
- 54288-160 is the product NDC for Potassium Chloride, Potassium chloride 20 meq/15mL solution, listed with the FDA by BPI Labs LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Chloride.
- 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?
- 218 other product NDCs are listed under this name. See all Potassium Chloride 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 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 Chloridepotassium chloride oral | Potassium chloride 1.5 g/15mL | SolutionOral | Cardinal Health 107, LLC | 55154-8026 | 55154-8026-05 |
| Potassium Chloride | Potassium chloride 1.5 g/1.58g | Powder, For solutionOral | Cardinal Health 107, LLC | 55154-8352 | 55154-8352-05 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-1032 | 67046-1032-03 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-423 | 60760-0423-90 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-111 | 82868-0111-90 |
| Potassium Chloride | Potassium chloride 20 meq/15mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-411 | 82983-0411-47 |
| Potassium Chloride | Potassium chloride 40 meq/15mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-412 | 82983-0412-47 |
| Potassium Chloride | Potassium chloride 20 meq/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7548 | 00904-7548-61 |
| Potassium Chloride | Potassium chloride 3 g/3.16g | For solutionOral | IPG Pharmaceuticals, Inc. | 71085-083 | 71085-0083-30 |
| Potassium Chloride | Potassium chloride 20 meq/15mL | SolutionOral | Aurobindo Pharma Limited | 59651-959 | 59651-0959-47 |
Other NDCs under ANDA 216156
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 | BPI Labs LLC | 54288-161 |
| Potassium Chloride | Potassium chloride 20 meq/15mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-411 |
| Potassium Chloride | Potassium chloride 40 meq/15mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-412 |