Prescription drug · NDA AUTHORIZED GENERIC
Potassium Citrate NDC 44523-415
Potassium citrate 15 meq/1 · Tablet · Oral · Biocomp Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44523-415-01 | 4452304150144523041501 | 100 TABLET in 1 BOTTLE (44523-415-01)Marketed from Dec 23, 2013 |
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 — 15 meq/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Biocomp Pharma, Inc.NDC labeler code 44523
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019071
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 44523-415_461546fa-70f8-dad0-e063-6394a90a4675SPL ID 461546fa-70f8-dad0-e063-6394a90a4675SPL set ID b32fe71a-4a58-04a1-64d3-bc3cc4a895bfRxCUI 199381, 898490UNII EE90ONI6FFUPC 0344523410015, 0344523415010
- 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
N444523041501followed by a unit qualifier and the quantityPackage 44523-0415-01. 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)
1 INDICATIONS AND USAGE 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 Stones Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)]. Potassium Citrate is a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium ston…
Excerpt only. Read the full label for complete information.
About NDC 44523-415
- What is NDC 44523-415?
- 44523-415 is the product NDC for Potassium Citrate, Potassium citrate 15 meq/1 tablet, listed with the FDA by Biocomp Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Citrate.
- What is the active ingredient?
- Potassium citrate.
- Who is the labeler?
- Biocomp Pharma, Inc., NDC labeler code 44523. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Potassium Citrate?
- 37 other product NDCs are listed under this name. See all Potassium Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Potassium Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4477 | 70518-4477-00 |
| Potassium Citrate | Potassium citrate 540 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-864 | 16571-0864-01 |
| Potassium Citrate | Potassium citrate 1080 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-865 | 16571-0865-01 |
| Potassium Citrate | Potassium citrate 10 meq/1 | TabletOral | Biocomp Pharma, Inc. | 44523-410 | 44523-0410-01 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3160 | 70518-3160-00 |
| Potassium Citrate | Potassium citrate 5 meq/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-191 | 72865-0191-01 |
| Potassium Citrate | Potassium citrate 5 meq/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-129 | 31722-0129-01 |
| Potassium Citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-130 | 31722-0130-01 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-132 | 31722-0132-01 |
| Potassium Citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2897 | 71335-2897-01 |
Other NDCs under NDA 019071
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 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0070 |
| Potassium Citrate | Potassium citrate 10 meq/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0071 |
| Potassium Citrate | Potassium citrate 10 meq/1 | TabletOral | Biocomp Pharma, Inc. | 44523-410 |
| Urocit-Kpotassium citrate | Potassium citrate 10 meq/1 | Tablet, Extended releaseOral | Mission Pharmacal Company | 0178-0610 |
| Urocit-Kpotassium citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Mission Pharmacal Company | 0178-0615 |