What is NDC 0121-0676?

0121-0676 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 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?

Potassium Citrate and Citric Acid (Potassium Citrate and Citric Acid Monohydrate).

What is the active ingredient?

Potassium citrate, Citric acid monohydrate.

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 Potassium Citrate and Citric Acid?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Potassium Citrate and Citric Acid NDC 0121-0676

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0676Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0676Add 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 NDC	11-digit (billing)	Package	Copy
0121-0676-16	0012106761600121067616	473 mL in 1 BOTTLE (0121-0676-16)Marketed from Oct 7, 1997

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 and Citric Acid
Generic name (nonproprietary): potassium citrate and citric acid monohydrate
Active ingredients: Potassium citrate — 1100 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: Oct 7, 1997
Listing expires: Dec 31, 2026
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 0121-0676_a89c03e3-61a9-46df-9de7-e73f522f123dSPL ID a89c03e3-61a9-46df-9de7-e73f522f123dSPL set ID ce42122f-8087-471f-b0a3-5524bdbd4526RxCUI 309318UNII EE90ONI6FF, 2968PHW8QPUPC 0301210676161
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

N400121067616 followed by a unit qualifier and the quantity

Package 00121-0676-16. 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 Nov 19, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Potassium Citrate and Citric Acid Oral Solution USP 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, a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0676

What is NDC 0121-0676?: 0121-0676 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 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?: Potassium Citrate and Citric Acid (Potassium Citrate and Citric Acid Monohydrate).
What is the active ingredient?: Potassium 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 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.

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

Other Potassium Citrate and Citric Acid NDCs
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 RX, LLC	62135-435	62135-0435-2462135-0435-47
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