NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8639Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8639Add 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
68788-8639-16878886390168788863901100 TABLET, FILM COATED in 1 BOTTLE (68788-8639-1)Marketed from Apr 18, 2024
68788-8639-3687888639036878886390330 TABLET, FILM COATED in 1 BOTTLE (68788-8639-3)Marketed from Apr 18, 2024
68788-8639-5687888639056878886390550 TABLET, FILM COATED in 1 BOTTLE (68788-8639-5)Marketed from Apr 18, 2024
68788-8639-6687888639066878886390660 TABLET, FILM COATED in 1 BOTTLE (68788-8639-6)Marketed from Apr 18, 2024
68788-8639-9687888639096878886390990 TABLET, FILM COATED in 1 BOTTLE (68788-8639-9)Marketed from Apr 18, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Losortan Potassium
Generic name (nonproprietary)
losartan potassium
Active ingredients
Losartan potassium — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078243
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 68788-8639_0cf5c1aa-fe22-4d4f-91d1-e8706975f44eSPL ID 0cf5c1aa-fe22-4d4f-91d1-e8706975f44eSPL set ID 25651749-8950-43ff-bcbd-3bb85f57a360RxCUI 979485UNII 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

N468788863901 followed by a unit qualifier and the quantity

Package 68788-8639-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Losartan potassium tablets 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 potassium t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8639

What is NDC 68788-8639?
68788-8639 is the product NDC for Losortan Potassium (losartan potassium), Losartan potassium 25 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Losortan Potassium (Losartan Potassium).
What is the active ingredient?
Losartan potassium.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Losortan Potassium?
6 other product NDCs are listed under this name. See all Losortan 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 Losortan Potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Losortan Potassiumlosartan potassiumLosartan potassium 25 mg/1Tablet, Film coatedOralAvPAK50268-50450268-0504-15
Losortan Potassiumlosartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralAvPAK50268-50550268-0505-15
Losortan Potassiumlosartan potassiumLosartan potassium 100 mg/1Tablet, Film coatedOralAvPAK50268-50650268-0506-15
Losortan Potassiumlosartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-07163187-0071-3063187-0071-6063187-0071-90
Losortan Potassiumlosartan potassiumLosartan potassium 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-07263187-0072-3063187-0072-6063187-0072-90
Losortan Potassiumlosartan potassiumLosartan potassium 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-164471335-1644-0171335-1644-0271335-1644-03+3 more

Other NDCs under ANDA 078243

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

FDA NDC Directory listings under ANDA 078243
ProductStrengthForm · routeLabelerProduct NDC
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4783
Losortan Potassiumlosartan potassiumLosartan potassium 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-071
Losortan Potassiumlosartan potassiumLosartan potassium 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-072
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2089
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-7958
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-135
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-136
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-137
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-7959
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2326
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2327
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2333
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6643
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-7960
Losortan Potassiumlosartan potassiumLosartan potassium 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1644
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-731
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-729
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-730
Losortan Potassiumlosartan potassiumLosartan potassium 100 mg/1Tablet, Film coatedOralAvPAK50268-506
Losortan Potassiumlosartan potassiumLosartan potassium 25 mg/1Tablet, Film coatedOralAvPAK50268-504

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