Prescription drug · UNAPPROVED DRUG OTHER
Potassium Citrate and Citric Acid NDC 62135-435
Potassium citrate 1100 mg/5mL; Citric acid monohydrate 334 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-435-24 | 62135043524 | 2 TRAY in 1 BOX (62135-435-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-435-05)Marketed from Apr 4, 2025 | |
| 62135-435-47 | 62135043547 | 473 mL in 1 BOTTLE (62135-435-47)Marketed from Dec 8, 2022 |
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 and Citric Acid
- Generic name (nonproprietary)
- potassium citrate and citric acid
- Active ingredients
- Potassium citrate — 1100 mg/5mLCitric acid monohydrate — 334 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 62135-435_32598dec-73a0-13fd-e063-6294a90ad1ceSPL ID 32598dec-73a0-13fd-e063-6294a90ad1ceSPL set ID 978a5a9d-f0ca-4308-a84b-3b132263bbb8RxCUI 309318UNII EE90ONI6FF, 2968PHW8QPUPC 0362135435479
- 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
N462135043524followed by a unit qualifier and the quantityPackage 62135-0435-24. 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)
INDICATIONS AND USAGE Potassium citrate and citric acid oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. This product is highly concentrated, and w…
Excerpt only. Read the full label for complete information.
About NDC 62135-435
- What is NDC 62135-435?
- 62135-435 is the product NDC for Potassium Citrate and Citric Acid, Potassium citrate 1100 mg/5mL; Citric acid monohydrate 334 mg/5mL solution, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Citrate and Citric Acid.
- What is the active ingredient?
- Potassium citrate, Citric acid monohydrate.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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 and Citric Acid?
- 2 other product NDCs are listed under this name. See all Potassium Citrate and Citric Acid 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 and Citric Acid 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 and Citric Acid | Potassium citrate 1100 mg/5mL; Citric acid monohydrate 334 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-435 | 68999-0435-24 |
| Potassium Citrate and Citric Acidpotassium citrate and citric acid monohydrate | Potassium citrate 1100 mg/5mL; Citric acid monohydrate 334 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0676 | 00121-0676-16 |