NDC codes

FDA NDC Directory
Product NDC (as listed)33342-418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0418Add 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
33342-418-113334204181133342041811100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-418-11)Marketed from Sep 8, 2024
33342-418-12333420418123334204181210 BLISTER PACK in 1 CARTON (33342-418-12) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 8, 2024
33342-418-153334204181533342041815500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-418-15)Marketed from Sep 8, 2024
33342-418-34333420418343334204183410 BLISTER PACK in 1 CARTON (33342-418-34) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 8, 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 chloride
Generic name (nonproprietary)
potassium chloride
Active ingredients
Potassium chloride — 750 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212987
Marketing start
Listing expires
Other FDA classes
Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
Identifiers
Product ID 33342-418_e0562a05-4359-4256-87e3-fcde65a008cdSPL ID e0562a05-4359-4256-87e3-fcde65a008cdSPL set ID e0562a05-4359-4256-87e3-fcde65a008cdRxCUI 312529, 628953UNII 660YQ98I10UPC 0333342417114, 0333342418111, 0333342418159, 0333342417152
Pharmacologic class
Osmotic Laxative; Potassium Salt

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

N433342041811 followed by a unit qualifier and the quantity

Package 33342-0418-11. 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 chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release tablets is a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-418

What is NDC 33342-418?
33342-418 is the product NDC for Potassium chloride, Potassium chloride 750 mg/1 tablet, film coated, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Potassium chloride.
What is the active ingredient?
Potassium chloride.
Who is the labeler?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 chloride?
216 other product NDCs are listed under this name. See all Potassium chloride 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 chloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Potassium Chloridepotassium chloride oralPotassium chloride 1.5 g/15mLSolutionOralCardinal Health 107, LLC55154-802655154-8026-05
Potassium ChloridePotassium chloride 1.5 g/1.58gPowder, For solutionOralCardinal Health 107, LLC55154-835255154-8352-05
Potassium ChloridePotassium chloride 750 mg/1Tablet, Film coated, Extended releaseOralCoupler LLC67046-103267046-1032-03
Potassium ChloridePotassium chloride 750 mg/1Tablet, Film coated, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-42360760-0423-90
Potassium ChloridePotassium chloride 750 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC82868-11182868-0111-90
Potassium ChloridePotassium chloride 20 meq/15mLSolutionOralAjenat Pharmaceuticals LLC82983-41182983-0411-47
Potassium ChloridePotassium chloride 40 meq/15mLSolutionOralAjenat Pharmaceuticals LLC82983-41282983-0412-47
Potassium ChloridePotassium chloride 20 meq/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-754800904-7548-61
Potassium ChloridePotassium chloride 3 g/3.16gFor solutionOralIPG Pharmaceuticals, Inc.71085-08371085-0083-30
Potassium ChloridePotassium chloride 20 meq/15mLSolutionOralAurobindo Pharma Limited59651-95959651-0959-47

All 217 Potassium chloride NDCs

Other NDCs under ANDA 212987

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

FDA NDC Directory listings under ANDA 212987
ProductStrengthForm · routeLabelerProduct NDC
Potassium chloridePotassium chloride 600 mg/1Tablet, Film coated, Extended releaseOralMacleods Pharmaceuticals Limited33342-417

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