Prescription drug · NDA
Tribenzor NDC 0713-0876
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide · Olmesartan medoxomil 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0876-30 | 00713087630 | 30 TABLET, FILM COATED in 1 BOTTLE (0713-0876-30)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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200175
- Marketing start
- Listing expires
- 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 0713-0876_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 864V2Q084H, 0J48LPH2TH, 6M97XTV3HDUPC 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
N400713087630followed by a unit qualifier and the quantityPackage 00713-0876-30. 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 . 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.
- openFDA data updated
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