What is NDC 0713-0875?

0713-0875 is the product NDC for Tribenzor, Olmesartan medoxomil 40 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tribenzor (Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide).

What is the active ingredient?

Olmesartan medoxomil, Amlodipine besylate, Hydrochlorothiazide.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tribenzor?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tribenzor NDC 0713-0875 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0875Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0875Add 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
0713-0875-30	0071308753000713087530	30 TABLET, FILM COATED in 1 BOTTLE (0713-0875-30)Marketed from Sep 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Tribenzor
Generic name (nonproprietary): olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Active ingredients: Olmesartan medoxomil — 40 mg/1Amlodipine besylate — 5 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 200175
Marketing start: Sep 1, 2022
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 0713-0875_004953ba-fe11-03eb-e063-6394a90a638cSPL ID 004953ba-fe11-03eb-e063-6394a90a638cSPL set ID 2f56d0bc-236b-41a0-9fc0-21cdfea8d890RxCUI 999967, 999971, 999986, 999990, 999991, 999995, 999996, 1000000, 1000001, 1000005UNII 0J48LPH2TH, 6M97XTV3HD, 864V2Q084HUPC 0307130876308, 0307130874304, 0307130877305, 0307130878302, 0307130875301
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

N400713087530 followed by a unit qualifier and the quantity

Package 00713-0875-30. 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 Jul 12, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Tribenzor is 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 Tribenzor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic ther…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0875

What is NDC 0713-0875?: 0713-0875 is the product NDC for Tribenzor, Olmesartan medoxomil 40 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tribenzor (Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide).
What is the active ingredient?: Olmesartan medoxomil, Amlodipine besylate, Hydrochlorothiazide.
Who is the labeler?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tribenzor?: 4 other product NDCs are listed under this name. See all Tribenzor 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 Tribenzor NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 20 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0874	00713-0874-30
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0876	00713-0876-30
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0877	00713-0877-30
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0878	00713-0878-30

Other NDCs under NDA 200175

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

FDA NDC Directory listings under NDA 200175
Product	Strength	Form · route	Labeler	Product NDC
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 20 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0874
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0876
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0877
Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Olmesartan medoxomil 40 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-0878