What is NDC 68462-569?

68462-569 is the product NDC for Amlodipine and Olmesartan Medoxomil, Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Amlodipine besylate, Olmesartan medoxomil.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amlodipine and Olmesartan Medoxomil?

37 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amlodipine and Olmesartan Medoxomil NDC 68462-569

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-569Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0569Add 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
68462-569-14	6846205691468462056914	10 BLISTER PACK in 1 CARTON (68462-569-14) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 5, 2017
68462-569-30	6846205693068462056930	30 TABLET, FILM COATED in 1 BOTTLE (68462-569-30)Marketed from Jul 5, 2017
68462-569-90	6846205699068462056990	90 TABLET, FILM COATED in 1 BOTTLE (68462-569-90)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 — 10 mg/1Olmesartan medoxomil — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207807
Marketing start: Jul 5, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 68462-569_6de4a776-9973-4410-ae04-99544813d920SPL ID 6de4a776-9973-4410-ae04-99544813d920SPL set ID 2edf43fb-0755-4ffb-bc38-75a4e2432588RxCUI 730861, 730866, 730869, 730872UNII 6M97XTV3HD, 864V2Q084HUPC 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

N468462056914 followed by a unit qualifier and the quantity

Package 68462-0569-14. 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)

About NDC 68462-569

What is NDC 68462-569?: 68462-569 is the product NDC for Amlodipine and Olmesartan Medoxomil, Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amlodipine and Olmesartan Medoxomil.
What is the active ingredient?: Amlodipine besylate, Olmesartan medoxomil.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amlodipine and Olmesartan Medoxomil?: 37 other product NDCs are listed under this name. See all Amlodipine and Olmesartan Medoxomil NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amlodipine and Olmesartan Medoxomil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-445	31722-0445-3031722-0445-90
Amlodipine and Olmesartan Medoxomilaamlodipine and olmesartan medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-446	31722-0446-3031722-0446-90
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-447	31722-0447-3031722-0447-90
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-448	31722-0448-3031722-0448-90
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	AvKARE	42291-001	42291-0001-30
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	AvKARE	42291-002	42291-0002-30
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	AvKARE	42291-003	42291-0003-30
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	AvKARE	42291-004	42291-0004-30
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc	50228-365	50228-0365-1050228-0365-3050228-0365-90
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc	50228-366	50228-0366-1050228-0366-3050228-0366-90

All 38 Amlodipine and Olmesartan Medoxomil NDCs

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 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-568