Potassium Citrate NDC 16571-864

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-864Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0864Add 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
16571-864-01	16571086401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-864-01)Marketed from Dec 15, 2024

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
Generic name (nonproprietary): potassium citrate
Active ingredients: Potassium citrate — 540 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077440
Marketing start: Dec 15, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 16571-864_73e193b2-7b67-4a83-9f5c-9b20ae32e779SPL ID 73e193b2-7b67-4a83-9f5c-9b20ae32e779SPL set ID 164d9d05-fbb1-4d99-8ba3-ff9c172aa8caRxCUI 199376, 199381UNII EE90ONI6FF
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

N416571086401 followed by a unit qualifier and the quantity

Package 16571-0864-01. 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 Jul 14, 2026.

Indications (excerpt from the label)

Potassium citrate is a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones ( 1.1 ) Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2 ) Uric acid lithiasis with or without calcium stones ( 1.3 ) 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 citr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077440

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077440
Product	Strength	Form · route	Labeler	Product NDC
Potassium Citrate	Potassium citrate 1080 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-865