Prescription drug · ANDA

Potassium Citrate NDC 68382-537

Potassium citrate 10 meq/1 · Tablet, Extended release · Oral · Zydus Pharmaceuticals (USA) Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68382-537Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0537Add 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 NDC11-digit (billing)PackageCopy
68382-537-0168382053701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-01)Marketed from Aug 12, 2014
68382-537-0568382053705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-05)Marketed from Aug 12, 2014
68382-537-066838205370630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-06)Marketed from Aug 12, 2014
68382-537-10683820537101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-10)Marketed from Aug 12, 2014
68382-537-166838205371690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-16)Marketed from Aug 12, 2014
68382-537-306838205373010 BLISTER PACK in 1 CARTON (68382-537-30) / 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203546
Marketing start
Listing expires
Other FDA classes
Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers
Product ID 68382-537_b0382b88-fcc4-44de-b66d-a93dabc596f8SPL ID b0382b88-fcc4-44de-b66d-a93dabc596f8SPL set ID 1a839f91-9bbd-4f46-b350-c5e8074b5db7RxCUI 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

N468382053701 followed by a unit qualifier and the quantity

Package 68382-0537-01. 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 .

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)

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
ProductStrengthForm · routeLabelerProduct NDC
Potassium CitratePotassium citrate 5 meq/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-536
Potassium CitratePotassium citrate 15 meq/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-538
Potassium CitratePotassium citrate 10 meq/1Tablet, Extended releaseOralAmerican Health Packaging68084-850
Potassium CitratePotassium citrate 5 meq/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-449
Potassium CitratePotassium citrate 10 meq/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-450
Potassium CitratePotassium citrate 15 meq/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-451
Potassium CitratePotassium citrate 5 meq/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-536
Potassium CitratePotassium citrate 10 meq/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-537
Potassium CitratePotassium citrate 15 meq/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-538

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Potassium Citrate NDC 68382-537 | Med-Code