Prescription drug · ANDA
Potassium Chloride Extended-Release NDC 82804-057
potassium chloride · Potassium chloride 1500 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-057-30 | 82804005730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-057-30)Marketed from Jan 15, 2024 | |
| 82804-057-60 | 82804005760 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-057-60)Marketed from Jan 15, 2024 | |
| 82804-057-90 | 82804005790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-057-90)Marketed from Jan 15, 2024 |
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-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 1500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209688
- 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 82804-057_d0ce0bdf-5f24-4093-813f-881c61d7fcc7SPL ID d0ce0bdf-5f24-4093-813f-881c61d7fcc7SPL set ID d0ce0bdf-5f24-4093-813f-881c61d7fcc7RxCUI 198116UNII 660YQ98I10UPC 0382804057306
- 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
N482804005730followed by a unit qualifier and the quantityPackage 82804-0057-30. 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 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.
Other NDCs under ANDA 209688
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 | A-S Medication Solutions | 50090-6639 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6640 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-231 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-232 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2447 |
| Potassium Chloride Extended-Releasepotassium chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-935 |