NDC codes

FDA NDC Directory
Product NDC (as listed)46708-447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0447Add 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
46708-447-30467080447304670804473030 TABLET, FILM COATED in 1 BOTTLE (46708-447-30)Marketed from May 23, 2016
46708-447-314670804473146708044731100 TABLET, FILM COATED in 1 BOTTLE (46708-447-31)Marketed from May 23, 2016
46708-447-90467080447904670804479090 TABLET, FILM COATED in 1 BOTTLE (46708-447-90)Marketed from May 23, 2016
46708-447-9146708044791467080447911000 TABLET, FILM COATED in 1 BOTTLE (46708-447-91)Marketed from May 23, 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
Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090428
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 46708-447_cedeb352-a540-4778-84e6-304f898fe17fSPL ID cedeb352-a540-4778-84e6-304f898fe17fSPL set ID eeb77c84-38d3-432d-914a-54b312b374bdRxCUI 979480, 979485, 979492UNII 3ST302B24AUPC 0346708447304, 0346708445300, 0346708446307

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

N446708044730 followed by a unit qualifier and the quantity

Package 46708-0447-30. 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 tablet USP is 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 table…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-447

What is NDC 46708-447?
46708-447 is the product NDC for Losartan Potassium, Losartan potassium 100 mg/1 tablet, film coated, listed with the FDA by Alembic 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?
Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 090428

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

FDA NDC Directory listings under ANDA 090428
ProductStrengthForm · routeLabelerProduct NDC
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-445
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-446
Losartan PotassiumLosartan potassium 25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-027
Losartan PotassiumLosartan potassium 50 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-028
Losartan PotassiumLosartan potassium 100 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-029

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