Olmesartan medoxomil Amlodipine and Hydrochlorothiazide NDC 33342-243

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-243Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0243Add 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 NDC	11-digit (billing)	Package	Copy
33342-243-07	33342024307	30 TABLET, FILM COATED in 1 BOTTLE (33342-243-07)Marketed from Jul 18, 2025
33342-243-10	33342024310	90 TABLET, FILM COATED in 1 BOTTLE (33342-243-10)Marketed from Jul 18, 2025

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 Amlodipine and Hydrochlorothiazide
Generic name (nonproprietary): olmesartan medoxomil amlodipine and hydrochlorothiazide
Active ingredients: Olmesartan medoxomil — 20 mg/1Amlodipine besylate — 5 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207088
Marketing start: Jul 18, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 33342-243_52c013e1-8c31-4bed-9241-e7845873ebe8SPL ID 52c013e1-8c31-4bed-9241-e7845873ebe8SPL set ID 52c013e1-8c31-4bed-9241-e7845873ebe8RxCUI 999967, 999986, 999991, 999996, 1000001UNII 864V2Q084H, 0J48LPH2TH, 6M97XTV3HDUPC 0333342247070, 0333342245076
Pharmacologic class: Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel 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

N433342024307 followed by a unit qualifier and the quantity

Package 33342-0243-07. 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 Aug 4, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. 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, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive car…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207088

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

FDA NDC Directory listings under ANDA 207088
Product	Strength	Form · route	Labeler	Product NDC
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-245
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-244
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-246
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-247