NDC codes

FDA NDC Directory
Product NDC (as listed)43547-392Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0392Add 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
43547-392-034354703920330 TABLET in 1 BOTTLE (43547-392-03)Marketed from Apr 24, 2017
43547-392-094354703920990 TABLET in 1 BOTTLE (43547-392-09)Marketed from Apr 24, 2017
43547-392-11435470392111000 TABLET in 1 BOTTLE (43547-392-11)Marketed from Apr 24, 2017

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 and HYDROCHLOROTHIAZIDE
Generic name (nonproprietary)
olmesartan medoxomil and hydrochlorothiazide
Active ingredients
Olmesartan medoxomil — 40 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207804
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 43547-392_23c860d3-1b9a-4113-bab4-b803492bf7d7SPL ID 23c860d3-1b9a-4113-bab4-b803492bf7d7SPL set ID bdca31d3-60b1-4659-aef7-56530b4f9039RxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0343547392093, 0343547391096, 0343547393090
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

N443547039203 followed by a unit qualifier and the quantity

Package 43547-0392-03. 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 and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2 )] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207804

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

FDA NDC Directory listings under ANDA 207804
ProductStrengthForm · routeLabelerProduct NDC
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1TabletOralSolco Healthcare US, LLC43547-393
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralSolco Healthcare US, LLC43547-391
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1TabletOralA-S Medication Solutions50090-7045
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralBryant Ranch Prepack71335-2424
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1TabletOralBryant Ranch Prepack71335-2425
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralA-S Medication Solutions50090-7127
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralA-S Medication Solutions50090-6836
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralBryant Ranch Prepack71335-9686

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