What is NDC 69238-2673?

69238-2673 is the product NDC for Amlodipine and Olmesartan Medoxomil, Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amlodipine besylate, Olmesartan medoxomil.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 69238-2673

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-2673Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-2673Add 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
69238-2673-1	6923826730169238267301	1000 TABLET, FILM COATED in 1 BOTTLE (69238-2673-1)Marketed from Dec 3, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209010
Marketing start: Dec 3, 2018
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 69238-2673_31d0d1f2-a0c7-4cd3-80d2-d9f231687adcSPL ID 31d0d1f2-a0c7-4cd3-80d2-d9f231687adcSPL set ID 02f9b562-6f7f-4783-bb0d-67c318073e1cRxCUI 730861, 730866, 730869, 730872UNII 6M97XTV3HD, 864V2Q084HUPC 0369238267617, 0369238267518, 0369238267310, 0369238267419
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

N469238267301 followed by a unit qualifier and the quantity

Package 69238-2673-01. 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 Mar 26, 2024. 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 69238-2673

What is NDC 69238-2673?: 69238-2673 is the product NDC for Amlodipine and Olmesartan Medoxomil, Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, 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?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 209010

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

FDA NDC Directory listings under ANDA 209010
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	AvKARE	42291-002
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	AvKARE	42291-003
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	AvKARE	42291-004
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc	50228-368
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc	50228-365
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc	50228-366
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc	50228-367
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-2676
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-2674
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-2675
Amlodipine and Olmesartan Medoxomil	Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1	Tablet, Film coatedOral	AvKARE	42291-001