Prescription drug · ANDA
Potassium Citrate Extended Release NDC 42543-406
potassium citrate · Potassium citrate 5 meq/1 · Tablet · Oral · Strides Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42543-406-01 | 42543040601 | 100 TABLET in 1 BOTTLE (42543-406-01)Marketed from Nov 1, 2017 |
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 Extended ReleaseSuffix: EXTENDED RELEASE
- Generic name (nonproprietary)
- potassium citrate
- Active ingredients
- Potassium citrate — 5 meq/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strides Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206813
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 42543-406_e9e76355-cc27-427b-a787-7628a4b88eb7SPL ID e9e76355-cc27-427b-a787-7628a4b88eb7SPL set ID 5f38b02c-703c-4fc2-b833-654e41bd617fRxCUI 199376, 199381, 898490UNII EE90ONI6FFUPC 0342543408012, 0342543406018, 0342543407015
- 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
N442543040601followed by a unit qualifier and the quantityPackage 42543-0406-01. 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 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 Llithiasis with or without Calcium Stones Potassium citra…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206813
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 Extended Releasepotassium citrate | Potassium citrate 15 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2478 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 71335-2871 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 5 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2476 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2477 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Strides Pharma Inc. | 42543-407 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 15 meq/1 | TabletOral | Strides Pharma Inc. | 42543-408 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 71335-1706 |