Prescription drug · ANDA
Potassium Chloride Extended Release (Potassium chloride) NDC 16571-842
Potassium chloride 600 mg/1 · Tablet, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-842-01 | 1657108420116571084201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-842-01)Marketed from Feb 13, 2025 | |
| 16571-842-10 | 1657108421016571084210 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-842-10)Marketed from Sep 18, 2025 | |
| 16571-842-50 | 1657108425016571084250 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-842-50)Marketed from Feb 13, 2025 |
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 Extended Release
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217412
- 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 16571-842_1e184d68-6ad3-484c-9b26-dc835ed91cbbSPL ID 1e184d68-6ad3-484c-9b26-dc835ed91cbbSPL set ID 947c11ca-ca0c-42df-8cc5-3db06458ca5bRxCUI 312529, 628953UNII 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
N416571084201followed by a unit qualifier and the quantityPackage 16571-0842-01. 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 extended-release tablets are 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 extended-release tablets are 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 16571-842
- What is NDC 16571-842?
- 16571-842 is the product NDC for Potassium Chloride Extended Release, Potassium chloride 600 mg/1 tablet, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Chloride Extended Release (Potassium chloride).
- What is the active ingredient?
- Potassium chloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 Extended Release?
- 45 other product NDCs are listed under this name. See all Potassium Chloride Extended Release 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 Extended Release 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 Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7547 | 00904-7547-61 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4520 | 70518-4520-00 |
| Potassium Chloride Extended-release | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4383 | 70518-4383-0070518-4383-0170518-4383-02 |
| Potassium Chloride Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-843 | 16571-0843-0116571-0843-1016571-0843-50 |
| Potassium Chloride Extended-release | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4095 | 70518-4095-0270518-4095-03 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-231 | 24979-0231-0124979-0231-0224979-0231-03 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-232 | 24979-0232-0124979-0232-02 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6639 | 50090-6639-0050090-6639-0150090-6639-02+1 more |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6640 | 50090-6640-00 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2447 | 71335-2447-0171335-2447-0271335-2447-03+4 more |
Other NDCs under ANDA 217412
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 Extended Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-843 |