NDC codes

FDA NDC Directory
Product NDC (as listed)78206-140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width78206-0140Add 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
78206-140-01782060140017820601400130 TABLET, FILM COATED in 1 BOTTLE (78206-140-01)Marketed from Jun 1, 2021
78206-140-02782060140027820601400290 TABLET, FILM COATED in 1 BOTTLE (78206-140-02)Marketed from Jun 1, 2021

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)
Hyzaar
Generic name (nonproprietary)
losartan potassium and hydrochlorothiazide
Active ingredients
Losartan potassium — 100 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Organon LLCNDC labeler code 78206
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020387
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 78206-140_10ae5107-90f4-4e30-9320-da164ad71bb7SPL ID 10ae5107-90f4-4e30-9320-da164ad71bb7SPL set ID 4116ccde-2e23-45f4-b12f-6337df877744RxCUI 979464, 979466, 979468, 979470, 979471, 979473UNII 0J48LPH2TH, 3ST302B24AUPC 0378206140012, 0378206139016, 0378206141019
Pharmacologic class
Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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

N478206014001 followed by a unit qualifier and the quantity

Package 78206-0140-01. 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)

HYZAAR is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. 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 ) 1.1 Hypertension HYZAAR ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strok…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 78206-140

What is NDC 78206-140?
78206-140 is the product NDC for Hyzaar, Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Organon LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hyzaar (Losartan potassium and hydrochlorothiazide).
What is the active ingredient?
Losartan potassium, Hydrochlorothiazide.
Who is the labeler?
Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hyzaar?
2 other product NDCs are listed under this name. See all Hyzaar 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 Hyzaar NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hyzaarlosartan potassium and hydrochlorothiazideLosartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralOrganon LLC78206-13978206-0139-0178206-0139-02
Hyzaarlosartan potassium and hydrochlorothiazideLosartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralOrganon LLC78206-14178206-0141-0178206-0141-02

Other NDCs under NDA 020387

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

FDA NDC Directory listings under NDA 020387
ProductStrengthForm · routeLabelerProduct NDC
Hyzaarlosartan potassium and hydrochlorothiazideLosartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralOrganon LLC78206-139
Hyzaarlosartan potassium and hydrochlorothiazideLosartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralOrganon LLC78206-141

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