NDC codes

FDA NDC Directory
Product NDC (as listed)33342-046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0046Add 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
33342-046-07333420046073334200460730 TABLET, FILM COATED in 1 BOTTLE (33342-046-07)Marketed from Jun 1, 2012
33342-046-10333420046103334200461090 TABLET, FILM COATED in 1 BOTTLE (33342-046-10)Marketed from Jun 1, 2012
33342-046-12333420046123334200461210 BLISTER PACK in 1 CARTON (33342-046-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 1, 2012
33342-046-4433342004644333420046441000 TABLET, FILM COATED in 1 BOTTLE (33342-046-44)Marketed from Jan 18, 2016

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)
Losartan potassium
Generic name (nonproprietary)
losartan potassium
Active ingredients
Losartan potassium — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202230
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 33342-046_81824d1f-61f4-457c-8723-cd43d5429029SPL ID 81824d1f-61f4-457c-8723-cd43d5429029SPL set ID 85d69d02-c5ef-467e-94aa-903100218795RxCUI 979480, 979485, 979492UNII 3ST302B24A

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

N433342004607 followed by a unit qualifier and the quantity

Package 33342-0046-07. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3 ) 1.1 Hypertension Losartan potass…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-046

What is NDC 33342-046?
33342-046 is the product NDC for Losartan potassium, Losartan potassium 100 mg/1 tablet, film coated, 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?
Losartan potassium.
What is the active ingredient?
Losartan potassium.
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 Losartan potassium?
173 other product NDCs are listed under this name. See all Losartan potassium 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 Losartan potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Losartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-87660760-0876-30
Losartan potassiumLosartan potassium 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-477370518-4773-00
Losartan PotassiumlosartanLosartan potassium 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-416068788-4160-0368788-4160-09
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-469570518-4695-0070518-4695-01
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-05287441-0052-01
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-05387441-0053-01
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralCoupler LLC67046-070267046-0702-03
Losartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-412768788-4127-0368788-4127-09
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralCoupler LLC67046-108867046-1088-03
Losartan potassiumLosartan potassium 25 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-409168788-4091-0368788-4091-09

All 174 Losartan potassium NDCs

Other NDCs under ANDA 202230

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

FDA NDC Directory listings under ANDA 202230
ProductStrengthForm · routeLabelerProduct NDC
Losartan potassiumLosartan potassium 25 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-044
Losartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-045
Losartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralCoupler LLC67046-1510
Losartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4127
Losartan potassiumLosartan potassium 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4289

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