Prescription drug · ANDA
Potassium Citrate NDC 68084-850
Potassium citrate 10 meq/1 · Tablet, Extended release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-850-32 | 68084085032 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-850-32) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-850-33)Marketed from Nov 12, 2014 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203546
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 68084-850_213c9f49-5d37-f84f-e063-6394a90aa698SPL ID 213c9f49-5d37-f84f-e063-6394a90aa698SPL set ID 1201c777-2388-4235-bb8f-eb7dc1e867f8RxCUI 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
N468084085032followed by a unit qualifier and the quantityPackage 68084-0850-32. 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 tablet is 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 Stone…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203546
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 | Zydus Pharmaceuticals (USA) Inc. | 68382-536 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-537 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-538 |
| Potassium Citrate | Potassium citrate 5 meq/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-449 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-450 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-451 |
| Potassium Citrate | Potassium citrate 5 meq/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-536 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-537 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-538 |