Prescription drug · ANDA
Potassium Citrate NDC 72865-191
Potassium citrate 5 meq/1 · Tablet, Extended release · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-191-01 | 72865019101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-191-01)Marketed from Feb 25, 2021 |
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 Citrate
- Generic name (nonproprietary)
- potassium citrate
- Active ingredients
- Potassium citrate — 5 meq/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214420
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 72865-191_7809b770-e255-4e34-b38f-90a0d51eeaeaSPL ID 7809b770-e255-4e34-b38f-90a0d51eeaeaSPL set ID 360a1012-4bdb-473a-8f1f-4550d3b51343RxCUI 199376, 199381, 898490UNII EE90ONI6FFUPC 0372865193013, 0372865191019, 0372865192016
- Pharmacologic class
- Anti-coagulant; Calculi Dissolution Agent
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
N472865019101followed by a unit qualifier and the quantityPackage 72865-0191-01. 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 citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] . 1.3 Uric Acid Lithiasis with or without Calcium Ston…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214420
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 Citrate | Potassium citrate 5 meq/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-129 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-130 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4477 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-132 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2897 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-192 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-193 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2120 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2121 |
| Potassium Citrate | Potassium citrate 5 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2122 |