Amlodipine and Olmesartan Medoxomil NDC 68462-568

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0568Add 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
68462-568-14	68462056814	10 BLISTER PACK in 1 CARTON (68462-568-14) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 5, 2017
68462-568-30	68462056830	30 TABLET, FILM COATED in 1 BOTTLE (68462-568-30)Marketed from Jul 5, 2017
68462-568-90	68462056890	90 TABLET, FILM COATED in 1 BOTTLE (68462-568-90)Marketed from Jul 5, 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): 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, Film coated
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207807
Marketing start: Jul 5, 2017
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 68462-568_6de4a776-9973-4410-ae04-99544813d920SPL ID 6de4a776-9973-4410-ae04-99544813d920SPL set ID 2edf43fb-0755-4ffb-bc38-75a4e2432588RxCUI 730861, 730866, 730869, 730872UNII 864V2Q084H, 6M97XTV3HDUPC 0368462568309, 0368462567302, 0368462569306, 0368462566305
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

N468462056814 followed by a unit qualifier and the quantity

Package 68462-0568-14. 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 Feb 28, 2021. 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 207807

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

FDA NDC Directory listings under ANDA 207807
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-566
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-567
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-569