Prescription drug · ANDA
Olmesartan Medoxomil And Hydrochlorothiazide NDC 16729-368
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-368-15 | 1672903681516729036815 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-368-15)Marketed from Sep 3, 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, Film coated
- Route
- Oral
- Labeler
- Accord Healthcare Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209281
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 16729-368_424dfa88-8ad1-1ec4-e063-6394a90a8dcfSPL ID 424dfa88-8ad1-1ec4-e063-6394a90a8dcfSPL set ID d858a6de-dda5-4bcd-a255-5723d01d896fRxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0316729368100, 0316729366106, 0316729367103
- 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
N416729036815followed by a unit qualifier and the quantityPackage 16729-0368-15. 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 16729-368
- What is NDC 16729-368?
- 16729-368 is the product NDC for Olmesartan Medoxomil And Hydrochlorothiazide, Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olmesartan Medoxomil And Hydrochlorothiazide.
- What is the active ingredient?
- Olmesartan medoxomil, Hydrochlorothiazide.
- Who is the labeler?
- Accord Healthcare Inc., NDC labeler code 16729. 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 Hydrochlorothiazide?
- 62 other product NDCs are listed under this name. See all Olmesartan Medoxomil 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 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 and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4780 | 70518-4780-00 |
| Olmesartan medoxomil and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4754 | 70518-4754-00 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-344 | 50228-0344-1050228-0344-3050228-0344-90 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-343 | 50228-0343-1050228-0343-3050228-0343-90 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-342 | 50228-0342-1050228-0342-3050228-0342-90 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-058 | 84677-0058-1084677-0058-90 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-056 | 84677-0056-1084677-0056-90 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-057 | 84677-0057-1084677-0057-90 |
| Olmesartan Medoxomil And Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4577 | 70518-4577-00 |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-025 | 60290-0025-0160290-0025-0260290-0025-03+2 more |
Other NDCs under ANDA 209281
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 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-366 |
| Olmesartan Medoxomil And Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-367 |
| Olmesartan Medoxomil And Hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5402 |