Amlodipine And Olmesartan Medoxomil NDC 42571-237

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-237Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0237Add 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
42571-237-05	42571023705	500 TABLET in 1 BOTTLE (42571-237-05)Marketed from Jan 1, 2018
42571-237-10	42571023710	1000 TABLET in 1 BOTTLE (42571-237-10)Marketed from Jan 1, 2018
42571-237-30	42571023730	30 TABLET in 1 BOTTLE (42571-237-30)Marketed from Jan 1, 2018
42571-237-90	42571023790	90 TABLET in 1 BOTTLE (42571-237-90)Marketed from Jan 1, 2018

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): Amlodipine And Olmesartan Medoxomil
Generic name (nonproprietary): amlodipine and olmesartan medoxomil
Active ingredients: Amlodipine besylate — 5 mg/1Olmesartan medoxomil — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207435
Marketing start: Jan 1, 2018
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)
Identifiers: Product ID 42571-237_2b531912-67b1-6172-e063-6394a90a178fSPL ID 2b531912-67b1-6172-e063-6394a90a178fSPL set ID 7fcf6a87-7b3e-4cef-8c47-c8a008cfea82RxCUI 730861, 730866, 730869, 730872UNII 864V2Q084H, 6M97XTV3HDUPC 0342571238308, 0342571237301, 0342571235307, 0342571236304
Pharmacologic class: Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker

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

N442571023705 followed by a unit qualifier and the quantity

Package 42571-0237-05. 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 Jan 9, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine and olmesartan medoxomil 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 amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207435

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

FDA NDC Directory listings under ANDA 207435
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine And Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1	TabletOral	Micro Labs Limited	42571-236
Amlodipine And Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	TabletOral	Micro Labs Limited	42571-235
Amlodipine And Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	TabletOral	Micro Labs Limited	42571-238
Amlodipine And Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-2379