Prescription drug · ANDA
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE NDC 71335-9686
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9686-1 | 71335968601 | 30 TABLET in 1 BOTTLE (71335-9686-1)Marketed from Apr 10, 2026 | |
| 71335-9686-2 | 71335968602 | 90 TABLET in 1 BOTTLE (71335-9686-2)Marketed from Apr 3, 2023 | |
| 71335-9686-3 | 71335968603 | 28 TABLET in 1 BOTTLE (71335-9686-3)Marketed from Apr 10, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207804
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71335-9686_6dc9fe8b-47ae-4aa9-b194-2ba4f0210d2dSPL ID 6dc9fe8b-47ae-4aa9-b194-2ba4f0210d2dSPL set ID 2c8bb018-af07-4745-a4e9-f9a6795a5ea2RxCUI 403854UNII 6M97XTV3HD, 0J48LPH2TH
- 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
N471335968601followed by a unit qualifier and the quantityPackage 71335-9686-01. 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 207804
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 40 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-393 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-391 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-392 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7045 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2424 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2425 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7127 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6836 |