Prescription drug · ANDA
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide NDC 33342-246
Olmesartan medoxomil 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-246-07 | 3334202460733342024607 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-246-07)Marketed from Jul 18, 2025 | |
| 33342-246-10 | 3334202461033342024610 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-246-10)Marketed from Jul 18, 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 Amlodipine and Hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil amlodipine and hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Amlodipine besylate — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207088
- 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 33342-246_52c013e1-8c31-4bed-9241-e7845873ebe8SPL ID 52c013e1-8c31-4bed-9241-e7845873ebe8SPL set ID 52c013e1-8c31-4bed-9241-e7845873ebe8RxCUI 999967, 999986, 999991, 999996, 1000001UNII 0J48LPH2TH, 6M97XTV3HD, 864V2Q084HUPC 0333342247070, 0333342245076
- 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
N433342024607followed by a unit qualifier and the quantityPackage 33342-0246-07. 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 (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, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive car…
Excerpt only. Read the full label for complete information.
About NDC 33342-246
- What is NDC 33342-246?
- 33342-246 is the product NDC for Olmesartan medoxomil Amlodipine and Hydrochlorothiazide, Olmesartan medoxomil 40 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olmesartan medoxomil Amlodipine and Hydrochlorothiazide.
- What is the active ingredient?
- Olmesartan medoxomil, Amlodipine besylate, Hydrochlorothiazide.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 Amlodipine and Hydrochlorothiazide?
- 19 other product NDCs are listed under this name. See all Olmesartan medoxomil Amlodipine and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olmesartan medoxomil Amlodipine and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEolmesartan medoxomil, amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Micro Labs Limited | 42571-245 | 42571-0245-0542571-0245-1042571-0245-30+1 more |
| OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEolmesartan medoxomil, amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Micro Labs Limited | 42571-246 | 42571-0246-0542571-0246-1042571-0246-30+1 more |
| OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEolmesartan medoxomil, amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Micro Labs Limited | 42571-247 | 42571-0247-0542571-0247-1042571-0247-30+1 more |
| OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEolmesartan medoxomil, amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Micro Labs Limited | 42571-248 | 42571-0248-0542571-0248-1042571-0248-30+1 more |
| OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEolmesartan medoxomil, amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Micro Labs Limited | 42571-249 | 42571-0249-0542571-0249-1042571-0249-30+1 more |
| Olmesartan medoxomil, amlodipine and hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-892 | 31722-0892-3031722-0892-3231722-0892-90 |
| Olmesartan medoxomil, amlodipine and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-893 | 31722-0893-3031722-0893-3231722-0893-90 |
| Olmesartan medoxomil, amlodipine and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-894 | 31722-0894-3031722-0894-3231722-0894-90 |
| Olmesartan medoxomil, amlodipine and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-895 | 31722-0895-3031722-0895-3231722-0895-90 |
| Olmesartan medoxomil, amlodipine and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-896 | 31722-0896-3031722-0896-3231722-0896-90 |
All 20 Olmesartan medoxomil Amlodipine and Hydrochlorothiazide NDCs
Other NDCs under ANDA 207088
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 Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-243 |
| Olmesartan medoxomil Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-244 |
| Olmesartan medoxomil Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-245 |
| Olmesartan medoxomil Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-247 |