Prescription drug · ANDA
Olmesartan Medoxomil and Hydrochlorothiazide NDC 70756-814
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-814-12 | 70756081412 | 1000 TABLET in 1 BOTTLE (70756-814-12)Marketed from Oct 1, 2020 | |
| 70756-814-30 | 70756081430 | 30 TABLET in 1 BOTTLE (70756-814-30)Marketed from Oct 1, 2020 | |
| 70756-814-51 | 70756081451 | 500 TABLET in 1 BOTTLE (70756-814-51)Marketed from Oct 1, 2020 | |
| 70756-814-90 | 70756081490 | 90 TABLET in 1 BOTTLE (70756-814-90)Marketed from Oct 1, 2020 |
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 Hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil and hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lifestar Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208847
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 70756-814_45806c19-480f-987e-e063-6394a90aa8faSPL ID 45806c19-480f-987e-e063-6394a90aa8faSPL set ID 9771066e-c05d-6a93-e053-2995a90a7e87RxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0370756814122
- 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
N470756081412followed by a unit qualifier and the quantityPackage 70756-0814-12. 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 tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2 )] . 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 olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208847
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 Hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-102 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5450 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2180 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-812 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-813 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-025 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-026 |