Prescription drug · ANDA
potassium chloride NDC 43547-553
Potassium chloride 750 mg/1 · Capsule, Extended release · Oral · Solco Healthcare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-553-10 | 43547055310 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43547-553-10)Marketed from Apr 30, 2019 | |
| 43547-553-50 | 43547055350 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43547-553-50)Marketed from Apr 30, 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
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 750 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Solco Healthcare LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209026
- 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 43547-553_580cdd01-0999-41cc-a4a1-6798a71ef6d5SPL ID 580cdd01-0999-41cc-a4a1-6798a71ef6d5SPL set ID 52d91d76-8c7f-40f1-9f5c-e05962cabeddRxCUI 312504, 315183UNII 660YQ98I10UPC 0343547553104, 0343547552107
- 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
N443547055310followed by a unit qualifier and the quantityPackage 43547-0553-10. 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 extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release capsules, USP contain potassium chloride, 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 43547-553
- What is NDC 43547-553?
- 43547-553 is the product NDC for potassium chloride, Potassium chloride 750 mg/1 capsule, extended release, listed with the FDA by Solco Healthcare LLC. It has 2 package NDCs, 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?
- Solco Healthcare LLC, NDC labeler code 43547. 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?
- 217 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 209026
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 600 mg/1 | Capsule, Extended releaseOral | Solco Healthcare LLC | 43547-552 |