Prescription drug · NDA
Potassium Chloride NDC 71610-349
Potassium chloride 750 mg/1 · Tablet, Film coated, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-349-15 | 7161003491571610034915 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-15)Marketed from Feb 8, 2022 | |
| 71610-349-30 | 7161003493071610034930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-30)Marketed from Oct 16, 2019 | |
| 71610-349-45 | 7161003494571610034945 | 45 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-45)Marketed from Feb 8, 2022 | |
| 71610-349-53 | 7161003495371610034953 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-53)Marketed from Oct 16, 2019 | |
| 71610-349-60 | 7161003496071610034960 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-60)Marketed from Oct 16, 2019 | |
| 71610-349-70 | 7161003497071610034970 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-70)Marketed from Oct 16, 2019 | |
| 71610-349-80 | 7161003498071610034980 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-80)Marketed from Oct 16, 2019 | |
| 71610-349-85 | 7161003498571610034985 | 200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-85)Marketed from Oct 16, 2019 | |
| 71610-349-92 | 7161003499271610034992 | 270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-92)Marketed from Oct 16, 2019 | |
| 71610-349-94 | 7161003499471610034994 | 360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-94)Marketed from Oct 16, 2019 | |
| 71610-349-98 | 7161003499871610034998 | 540 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-98)Marketed from Feb 8, 2022 |
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
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019123
- 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 71610-349_2b497b8f-a0e3-9ff7-e063-6394a90a3800SPL ID 2b497b8f-a0e3-9ff7-e063-6394a90a3800SPL set ID 81a53ecd-2612-4efe-9491-415fff3f86e5RxCUI 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
N471610034915followed by a unit qualifier and the quantityPackage 71610-0349-15. 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 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 is insufficient. Potassium chloride extended-release is 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 71610-349
- What is NDC 71610-349?
- 71610-349 is the product NDC for Potassium Chloride, Potassium chloride 750 mg/1 tablet, film coated, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 11 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?
- 216 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 NDA 019123
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 |
|---|---|---|---|---|
| Klor-Conpotassium chloride | Potassium chloride 600 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-5315 |
| Klor-Conpotassium chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-5316 |
| Potassium Chloride | Potassium chloride 600 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-5322 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-5323 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 42291-506 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7639 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7640 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-226 |