Prescription drug · ANDA
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide NDC 70436-015
Olmesartan medoxomil 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-015-04 | 70436001504 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-015-04)Marketed from May 15, 2025 | |
| 70436-015-06 | 70436001506 | 90 TABLET, FILM COATED in 1 BOTTLE (70436-015-06)Marketed from May 15, 2025 |
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)
- olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Amlodipine besylate — 5 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210718
- 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 70436-015_d306cb9e-4244-49dd-9297-9cb6ca69cae9SPL ID d306cb9e-4244-49dd-9297-9cb6ca69cae9SPL set ID a469adff-25a6-4983-b471-60924d920a86RxCUI 999967, 999986, 999991, 999996, 1000001UNII 0J48LPH2TH, 864V2Q084H, 6M97XTV3HDUPC 0370436018048, 0370436016044, 0370436014040, 0370436015047, 0370436017041
- 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
N470436001504followed by a unit qualifier and the quantityPackage 70436-0015-04. 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)
Olmesartan medoxomil, amlodipine, and hydrochlorothiazide 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 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 olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210718
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 |
|---|---|---|---|---|
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-016 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-014 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-017 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-018 |