Prescription drug · NDA
olmesartan medoxomil-hydrochlorothiazide NDC 42291-925
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-925-90 | 42291092590 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-925-90)Marketed from Jul 27, 2023 |
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-hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil-hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021532
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 42291-925_48bfa982-5678-139d-e063-6294a90adbfaSPL ID 48bfa982-5678-139d-e063-6294a90adbfaSPL set ID 017bc6a3-5b3d-2381-e063-6394a90abeceRxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0342291925908, 0342291924901
- Pharmacologic class
- Angiotensin 2 Receptor 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
N442291092590followed by a unit qualifier and the quantityPackage 42291-0925-90. 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 and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] . 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 and hydrochlorothiazide. Control of high …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021532
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-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-924 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-926 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-078 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-079 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-080 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0943 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0944 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0863 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0945 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0864 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0865 |