Prescription drug · ANDA
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide NDC 0093-5005
Olmesartan medoxomil 20 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5005-56 | 0009350055600093500556 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5005-56)Marketed from Nov 14, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 20 mg/1Amlodipine besylate — 5 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202491
- 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 0093-5005_a035edd9-948f-4168-b74b-9961a2cb219aSPL ID a035edd9-948f-4168-b74b-9961a2cb219aSPL set ID 5c128ef2-60a6-40f3-b37f-ee139fe27987RxCUI 999967, 999986, 999991, 999996, 1000001UNII 0J48LPH2TH, 6M97XTV3HD, 864V2Q084H
- 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
N400093500556followed by a unit qualifier and the quantityPackage 00093-5005-56. 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, 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 cardi…
Excerpt only. Read the full label for complete information.
About NDC 0093-5005
- What is NDC 0093-5005?
- 0093-5005 is the product NDC for Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide, Olmesartan medoxomil 20 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 202491
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 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5002 |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5003 |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5004 |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5006 |