Prescription drug · ANDA
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE NDC 43547-392
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-392-03 | 4354703920343547039203 | 30 TABLET in 1 BOTTLE (43547-392-03)Marketed from Apr 24, 2017 | |
| 43547-392-09 | 4354703920943547039209 | 90 TABLET in 1 BOTTLE (43547-392-09)Marketed from Apr 24, 2017 | |
| 43547-392-11 | 4354703921143547039211 | 1000 TABLET in 1 BOTTLE (43547-392-11)Marketed from Apr 24, 2017 |
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 — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- 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 43547-392_23c860d3-1b9a-4113-bab4-b803492bf7d7SPL ID 23c860d3-1b9a-4113-bab4-b803492bf7d7SPL set ID bdca31d3-60b1-4659-aef7-56530b4f9039RxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0343547392093, 0343547391096, 0343547393090
- 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
N443547039203followed by a unit qualifier and the quantityPackage 43547-0392-03. 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.
About NDC 43547-392
- What is NDC 43547-392?
- 43547-392 is the product NDC for OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE, Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. It has 3 package NDCs, 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?
- Solco Healthcare US, LLC, NDC labeler code 43547. 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 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 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 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 | A-S Medication Solutions | 50090-6836 |
| 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 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 | 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 | Bryant Ranch Prepack | 71335-9686 |