Prescription drug · UNAPPROVED DRUG OTHER
Tricitrates NDC 0121-0677
potassium citrate, sodium citrate, and citric acid monohydrate · Potassium citrate 550 mg/5mL + 2 more ingredients · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0677-16 | 0012106771600121067716 | 473 mL in 1 BOTTLE (0121-0677-16)Marketed from May 25, 2005 |
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)
- Tricitrates
- Generic name (nonproprietary)
- potassium citrate, sodium citrate, and citric acid monohydrate
- Active ingredients
- Potassium citrate — 550 mg/5mLSodium citrate — 500 mg/5mLCitric acid monohydrate — 334 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Acidifying Activity (Mechanism)Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Calcium Chelating Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Decreased Coagulation Factor Activity (Physiologic effect)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 0121-0677_3082f36b-0006-4aee-9019-38995d2292fdSPL ID 3082f36b-0006-4aee-9019-38995d2292fdSPL set ID 2ecb42a2-82f1-456b-8f1e-02c2d0a7b5adRxCUI 309317UNII EE90ONI6FF, 1Q73Q2JULR, 2968PHW8QPUPC 0301210677168
- 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
N400121067716followed by a unit qualifier and the quantityPackage 00121-0677-16. 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 ADVANTAGES Tricitrates SF 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. 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. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urine pH around the clock, usually without the necessity of a 2 A.M. dose. This …
Excerpt only. Read the full label for complete information.
About NDC 0121-0677
- What is NDC 0121-0677?
- 0121-0677 is the product NDC for Tricitrates, Potassium citrate 550 mg/5mL + 2 more ingredients solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tricitrates (POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE).
- What is the active ingredient?
- Potassium citrate, Sodium citrate, Citric acid monohydrate.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tricitrates?
- 2 other product NDCs are listed under this name. See all Tricitrates NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tricitrates products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tricitrates | Potassium citrate 550 mg/5mL + 2 more ingredients | SolutionOral | Chartwell RX, LLC | 62135-438 | 62135-0438-2462135-0438-47 |
| Tricitrates | Potassium citrate 550 mg/5mL + 2 more ingredients | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-438 | 68999-0438-24 |