Prescription drug · ANDA
Potassium Citrate NDC 62559-291
Potassium citrate 10 meq/1 · Tablet, Extended release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-291-01 | 62559029101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-291-01)Marketed from Mar 16, 2020 |
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 — 10 meq/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212779
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 62559-291_ce0ee9e0-f0bc-4578-b4cd-d3d353171e82SPL ID ce0ee9e0-f0bc-4578-b4cd-d3d353171e82SPL set ID 2fb31727-68b1-4183-947d-00e08bf99987RxCUI 199381, 898490UNII EE90ONI6FFUPC 0362559291019, 0362559292016
- 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
N462559029101followed by a unit qualifier and the quantityPackage 62559-0291-01. 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 wit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212779
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 10 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1758 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1759 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3160 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-292 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1967 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-1966 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-1967 |