Prescription drug · ANDA
Potassium Citrate NDC 63629-1966
Potassium citrate 10 meq/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1966-1 | 63629196601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1966-1)Marketed from Feb 8, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- 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 63629-1966_9b6284f1-1838-4fc0-8153-86189c6f89faSPL ID 9b6284f1-1838-4fc0-8153-86189c6f89faSPL set ID ebf1f1f1-4458-4d34-8432-21698a550e07RxCUI 199381UNII EE90ONI6FF
- 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
N463629196601followed by a unit qualifier and the quantityPackage 63629-1966-01. 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 10 meq/1 | Tablet, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-291 |
| 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 15 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-1967 |