Prescription drug · ANDA

Olmesartan Medoxomil NDC 82009-074

Olmesartan medoxomil 20 mg/1 · Tablet, Film coated · Oral · QUALLENT PHARMACEUTICALS HEALTH LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-074Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0074Add 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
82009-074-908200900749090 TABLET, FILM COATED in 1 BOTTLE (82009-074-90)Marketed from Aug 1, 2023

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)
Olmesartan Medoxomil
Generic name (nonproprietary)
olmesartan medoxomil
Active ingredients
Olmesartan medoxomil — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204798
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 82009-074_477067c5-6637-417d-8b4d-5efb555272ebSPL ID 477067c5-6637-417d-8b4d-5efb555272ebSPL set ID 98f930d5-f7c2-4870-92b4-0ad37ce45797RxCUI 349373, 349401, 349405UNII 6M97XTV3HDUPC 0382009073903

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

N482009007490 followed by a unit qualifier and the quantity

Package 82009-0074-90. 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)

Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204798

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

FDA NDC Directory listings under ANDA 204798
ProductStrengthForm · routeLabelerProduct NDC
Olmesartan MedoxomilOlmesartan medoxomil 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2362
Olmesartan MedoxomilOlmesartan medoxomil 40 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-075
Olmesartan MedoxomilOlmesartan medoxomil 5 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-073
Olmesartan MedoxomilOlmesartan medoxomil 40 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-743
Olmesartan MedoxomilOlmesartan medoxomil 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-741
Olmesartan MedoxomilOlmesartan medoxomil 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-742
Olmesartan MedoxomilOlmesartan medoxomil 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-172
Olmesartan MedoxomilOlmesartan medoxomil 40 mg/1Tablet, Film coatedOralProficient Rx LP71205-174
Olmesartan MedoxomilOlmesartan medoxomil 20 mg/1Tablet, Film coatedOralDirect_Rx72189-548
Olmesartan MedoxomilOlmesartan medoxomil 40 mg/1Tablet, Film coatedOralDirect_Rx72189-549

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Olmesartan Medoxomil NDC 82009-074 | Med-Code