What is NDC 65841-537?

65841-537 is the product NDC for Potassium Citrate, Potassium citrate 10 meq/1 tablet, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 65841. 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?

37 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 NDC 65841-537 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-537Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0537Add 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
65841-537-01	6584105370165841053701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-537-01)Marketed from Aug 12, 2014
65841-537-05	6584105370565841053705	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-537-05)Marketed from Aug 12, 2014
65841-537-06	6584105370665841053706	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-537-06)Marketed from Aug 12, 2014
65841-537-10	6584105371065841053710	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-537-10)Marketed from Aug 12, 2014
65841-537-16	6584105371665841053716	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-537-16)Marketed from Aug 12, 2014
65841-537-30	6584105373065841053730	10 BLISTER PACK in 1 CARTON (65841-537-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 12, 2014

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 — 10 meq/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 65841
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203546
Marketing start: Aug 12, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 65841-537_042721ed-7f5d-47f1-beff-b54ba88bcd27SPL ID 042721ed-7f5d-47f1-beff-b54ba88bcd27SPL set ID 39f46084-fc4b-4bfc-91cb-9be7e647655aRxCUI 199376, 199381, 898490UNII 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

N465841053701 followed by a unit qualifier and the quantity

Package 65841-0537-01. 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 Oct 3, 2023.

Indications (excerpt from the label)

Potassium citrate extended-release tablet 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65841-537

What is NDC 65841-537?: 65841-537 is the product NDC for Potassium Citrate, Potassium citrate 10 meq/1 tablet, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Potassium Citrate.
What is the active ingredient?: Potassium citrate.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 65841. 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?: 37 other product NDCs are listed under this name. See all Potassium Citrate 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Potassium Citrate	Potassium citrate 10 meq/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4477	70518-4477-00
Potassium Citrate	Potassium citrate 540 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-864	16571-0864-01
Potassium Citrate	Potassium citrate 1080 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-865	16571-0865-01
Potassium Citrate	Potassium citrate 10 meq/1	TabletOral	Biocomp Pharma, Inc.	44523-410	44523-0410-01
Potassium Citrate	Potassium citrate 10 meq/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-3160	70518-3160-00
Potassium Citrate	Potassium citrate 5 meq/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-191	72865-0191-01
Potassium Citrate	Potassium citrate 5 meq/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc	31722-129	31722-0129-01
Potassium Citrate	Potassium citrate 10 meq/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc	31722-130	31722-0130-01
Potassium Citrate	Potassium citrate 15 meq/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc	31722-132	31722-0132-01
Potassium Citrate	Potassium citrate 15 meq/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2897	71335-2897-01

All 38 Potassium Citrate NDCs

Other NDCs under ANDA 203546

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

FDA NDC Directory listings under ANDA 203546
Product	Strength	Form · route	Labeler	Product NDC
Potassium Citrate	Potassium citrate 5 meq/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-449
Potassium Citrate	Potassium citrate 10 meq/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-450
Potassium Citrate	Potassium citrate 15 meq/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-451
Potassium Citrate	Potassium citrate 5 meq/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	65841-536
Potassium Citrate	Potassium citrate 15 meq/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	65841-538
Potassium Citrate	Potassium citrate 10 meq/1	Tablet, Extended releaseOral	American Health Packaging	68084-850
Potassium Citrate	Potassium citrate 5 meq/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-536
Potassium Citrate	Potassium citrate 10 meq/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-537
Potassium Citrate	Potassium citrate 15 meq/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-538