Prescription drug · NDA
Urocit-K (Potassium citrate) NDC 0178-0610
Potassium citrate 10 meq/1 · Tablet, Extended release · Oral · Mission Pharmacal Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0178-0610-01 | 0017806100100178061001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0610-01)Marketed from Dec 30, 2009 |
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)
- Urocit-K
- Generic name (nonproprietary)
- potassium citrate
- Active ingredients
- Potassium citrate — 10 meq/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Mission Pharmacal CompanyNDC labeler code 0178
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication 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 0178-0610_572211af-57a0-9fac-e063-6394a90a1c75SPL ID 572211af-57a0-9fac-e063-6394a90a1c75SPL set ID 72cdea1b-2240-41db-987d-86d5c6aaa978RxCUI 199376, 199381, 603281, 603282, 898490, 898517UNII EE90ONI6FFUPC 0301780615010, 0301780600016, 0301780610015
- 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
N400178061001followed by a unit qualifier and the quantityPackage 00178-0610-01. 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)
1.1 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)]. Urocit-K is a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium o…
Excerpt only. Read the full label for complete information.
About NDC 0178-0610
- What is NDC 0178-0610?
- 0178-0610 is the product NDC for Urocit-K (potassium citrate), Potassium citrate 10 meq/1 tablet, extended release, listed with the FDA by Mission Pharmacal Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Urocit-K (Potassium citrate).
- What is the active ingredient?
- Potassium citrate.
- Who is the labeler?
- Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Urocit-K?
- 1 other product NDC are listed under this name. See all Urocit-K NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Urocit-K products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Urocit-Kpotassium citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Mission Pharmacal Company | 0178-0615 | 00178-0615-01 |
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 |
| Potassium Citrate | Potassium citrate 15 meq/1 | TabletOral | Biocomp Pharma, Inc. | 44523-415 |
| Urocit-Kpotassium citrate | Potassium citrate 15 meq/1 | Tablet, Extended releaseOral | Mission Pharmacal Company | 0178-0615 |