Prescription drug · NDA
Azor NDC 0713-0870
amlodipine besylate and olmesartan medoxomil · Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 · Tablet, Film coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0870-30 | 00713087030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0870-30)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)
- Azor
- Generic name (nonproprietary)
- amlodipine besylate and olmesartan medoxomil
- Active ingredients
- Amlodipine besylate — 5 mg/1Olmesartan medoxomil — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022100
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 0713-0870_00491aef-cf0c-eeb3-e063-6394a90a716dSPL ID 00491aef-cf0c-eeb3-e063-6394a90a716dSPL set ID c5535406-b63b-49aa-88b9-169aaf0ed08eRxCUI 730861, 730866, 730869, 730872, 744624, 744628, 744632, 744636UNII 864V2Q084H, 6M97XTV3HDUPC 0307130871303, 0307130873307, 0307130872300, 0307130870306
- 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
N400713087030followed by a unit qualifier and the quantityPackage 00713-0870-30. 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)
Azor 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 Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoki…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022100
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Azoramlodipine besylate and olmesartan medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0871 |
| Azoramlodipine besylate and olmesartan medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0872 |
| Azoramlodipine besylate and olmesartan medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0873 |
| amlodipine besylate and olmesartan medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-857 |
| amlodipine besylate and olmesartan medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-858 |
| amlodipine besylate and olmesartan medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-859 |
| amlodipine besylate and olmesartan medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-860 |