Prescription drug · ANDA
Potassium Citrate NDC 31722-129
Potassium citrate 5 meq/1 · Tablet, Extended release · Oral · Camber Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-129-01 | 31722012901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-129-01)Marketed from Feb 15, 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
- Camber 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 31722-129_cb7e4f56-0ffe-4809-991c-1751b62e63c7SPL ID cb7e4f56-0ffe-4809-991c-1751b62e63c7SPL set ID ea933654-e8d2-4662-9a9a-4a6d79a9fb20RxCUI 199376, 199381, 898490UNII EE90ONI6FFUPC 0331722130011, 0331722129015, 0331722132015
- 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
N431722012901followed by a unit qualifier and the quantityPackage 31722-0129-01. 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 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 5 meq/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-191 |
| 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 |