Prescription drug · ANDA
OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE NDC 42571-205
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-205-05 | 4257102050542571020505 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-205-05)Marketed from Oct 15, 2026 | |
| 42571-205-10 | 4257102051042571020510 | 1000 TABLET, FILM COATED in 1 BOTTLE (42571-205-10)Marketed from Oct 15, 2026 | |
| 42571-205-30 | 4257102053042571020530 | 30 TABLET, FILM COATED in 1 BOTTLE (42571-205-30)Marketed from Oct 15, 2026 | |
| 42571-205-90 | 4257102059042571020590 | 90 TABLET, FILM COATED in 1 BOTTLE (42571-205-90)Marketed from Oct 15, 2026 |
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 HYDROCHOLOROTHIAZIDE
- Generic name (nonproprietary)
- olmesartan medoxomil and hydrocholorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206371
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 42571-205_4f799eb1-290a-640c-e063-6294a90ac62bSPL ID 4f799eb1-290a-640c-e063-6294a90ac62bSPL set ID 576b315a-4830-42b5-bf5f-76fe4bbc0f8cRxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0342571206307, 0342571205300, 0342571204303
- 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
N442571020505followed by a unit qualifier and the quantityPackage 42571-0205-05. 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 [HCTZ] 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 managem…
Excerpt only. Read the full label for complete information.
About NDC 42571-205
- What is NDC 42571-205?
- 42571-205 is the product NDC for OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE, Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Micro Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE.
- What is the active ingredient?
- Olmesartan medoxomil, Hydrochlorothiazide.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 206371
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 HYDROCHOLOROTHIAZIDE | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-204 |
| OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-206 |