NDC codes

FDA NDC Directory
Product NDC (as listed)0121-0677Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-0677Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0121-0677-160012106771600121067716473 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

N400121067716 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tricitrates NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TricitratesPotassium citrate 550 mg/5mL + 2 more ingredientsSolutionOralChartwell RX, LLC62135-43862135-0438-2462135-0438-47
TricitratesPotassium citrate 550 mg/5mL + 2 more ingredientsSolutionOralChartwell Governmental & Specialty RX, LLC.68999-43868999-0438-24

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