Prescription drug · NDA
Benicar HCT (Olmesartan medoxomil-hydrochlorothiazide) NDC 0713-0945
Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0945-30 | 0071309453000713094530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0945-30)Marketed from Apr 1, 2026 |
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)
- Benicar HCT
- Generic name (nonproprietary)
- olmesartan medoxomil-hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021532
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 0713-0945_4caff105-c8ff-7873-e063-6294a90a5bfcSPL ID 4caff105-c8ff-7873-e063-6294a90a5bfcSPL set ID a90915ca-f9d3-4fff-8370-d5dc4cdfc521RxCUI 403853, 403854, 403855, 847042, 847055, 847060UNII 0J48LPH2TH, 6M97XTV3HD
- 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
N400713094530followed by a unit qualifier and the quantityPackage 00713-0945-30. 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)
BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 BENICAR HCT. Control of high blood pressure should be part of comprehensive cardi…
Excerpt only. Read the full label for complete information.
About NDC 0713-0945
- What is NDC 0713-0945?
- 0713-0945 is the product NDC for Benicar HCT (olmesartan medoxomil-hydrochlorothiazide), Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benicar HCT (Olmesartan medoxomil-hydrochlorothiazide).
- What is the active ingredient?
- Olmesartan medoxomil, Hydrochlorothiazide.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benicar HCT?
- 5 other product NDCs are listed under this name. See all Benicar HCT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benicar HCT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0943 | 00713-0943-30 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0944 | 00713-0944-30 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0863 | 00713-0863-30 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0864 | 00713-0864-30 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0865 | 00713-0865-30 |
Other NDCs under NDA 021532
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 |
|---|---|---|---|---|
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0863 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0864 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0865 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0943 |
| Benicar HCTolmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0944 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-924 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-925 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-926 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-078 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-079 |
| olmesartan medoxomil-hydrochlorothiazide | Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-080 |