Prescription drug · ANDA
Potassium Chloride NDC 0904-7461
Potassium chloride 20 meq/15mL · Solution · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7461-46 | 00904746146 | 30 CUP, UNIT-DOSE in 1 CASE (0904-7461-46) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88)Marketed from Jul 8, 2024 | |
| 0904-7461-47 | 00904746147 | 80 CUP, UNIT-DOSE in 1 CASE (0904-7461-47) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88)Marketed from Jul 11, 2024 | |
| 0904-7461-51 | 00904746151 | 50 CUP, UNIT-DOSE in 1 CASE (0904-7461-51) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88)Marketed from Jul 8, 2024 | |
| 0904-7461-80 | 00904746180 | 100 CUP, UNIT-DOSE in 1 CASE (0904-7461-80) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88)Marketed from Jul 8, 2024 | |
| 0904-7461-87 | 00904746187 | 40 CUP, UNIT-DOSE in 1 CASE (0904-7461-87) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88)Marketed from Jul 8, 2024 | |
| 0904-7461-88 | 00904746188 | 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88)Marketed from Jul 8, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210766
- 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 0904-7461_0e0defca-901d-4b4b-ac96-ac72fcfe4303SPL ID 0e0defca-901d-4b4b-ac96-ac72fcfe4303SPL set ID 33ad1eb2-1f05-461c-b01d-82dee4231556RxCUI 312515UNII 660YQ98I10UPC 0309047461882, 0309047462629
- 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
N400904746146followed by a unit qualifier and the quantityPackage 00904-7461-46. 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 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 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.
Other NDCs under ANDA 210766
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 20 meq/15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4948 |
| Potassium Chloride | Potassium chloride 40 meq/15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2847 |
| Potassium Chloride | Potassium chloride 40 meq/30mL | SolutionOral | Major Pharmaceuticals | 0904-7462 |
| Potassium Chloride | Potassium chloride 20 meq/30mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1896 |
| Potassium Chloride | Potassium chloride 20 meq/15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0948 |