Prescription drug · NDA
Potassium Citrate NDC 0245-0070
Potassium citrate 5 meq/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-0070-11 | 00245007011 | 100 TABLET in 1 BOTTLE (0245-0070-11)Marketed from Sep 1, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0245
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019071
- Marketing start
- Marketing end
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 0245-0070_39e81850-ac5b-656e-e063-6294a90a1d94SPL ID 39e81850-ac5b-656e-e063-6294a90a1d94SPL set ID 2215dc1d-0b5a-469e-9b51-4d7480a51078RxCUI 199376, 199381UNII EE90ONI6FFUPC 0302450071112
- 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
N400245007011followed by a unit qualifier and the quantityPackage 00245-0070-11. 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 lithiasis with or without calcium stones Potassium citrat…
Excerpt only. Read the full label for complete information.
About NDC 0245-0070
- What is NDC 0245-0070?
- 0245-0070 is the product NDC for Potassium Citrate, Potassium citrate 5 meq/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. 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?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0245. 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?
- 36 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 10 meq/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0071 |
| Potassium Citrate | Potassium citrate 10 meq/1 | TabletOral | Biocomp Pharma, Inc. | 44523-410 |
| Potassium Citrate | Potassium citrate 15 meq/1 | TabletOral | Biocomp Pharma, Inc. | 44523-415 |
| 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 |