Prescription drug · ANDA
Potassium Chloride (Potassium chloride extended-release) NDC 43547-551
Potassium chloride 1125 mg/1 · Tablet · Oral · Solco Healthcare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-551-10 | 43547055110 | 100 TABLET in 1 BOTTLE (43547-551-10)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 extended-release
- Active ingredients
- Potassium chloride — 1125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209922
- 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 43547-551_f704b746-ab75-4484-8704-5baa94a07750SPL ID f704b746-ab75-4484-8704-5baa94a07750SPL set ID f704b746-ab75-4484-8704-5baa94a07750RxCUI 403888, 1801294, 1801298UNII 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
N443547055110followed by a unit qualifier and the quantityPackage 43547-0551-10. 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)
INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading …
Excerpt only. Read the full label for complete information.
About NDC 43547-551
- What is NDC 43547-551?
- 43547-551 is the product NDC for Potassium Chloride (potassium chloride extended-release), Potassium chloride 1125 mg/1 tablet, listed with the FDA by Solco Healthcare LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Chloride (Potassium chloride extended-release).
- 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 209922
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 Chloridepotassium chloride extended-release | Potassium chloride 750 mg/1 | TabletOral | Solco Healthcare LLC | 43547-549 |
| Potassium Chloridepotassium chloride extended-release | Potassium chloride 1500 mg/1 | TabletOral | Solco Healthcare LLC | 43547-550 |