Prescription drug · NDA
Atacand Hct NDC 62559-650
candesartan cilexetil and hydrochlorothiazide · Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-650-90 | 62559065090 | 90 TABLET in 1 BOTTLE (62559-650-90)Marketed from Oct 1, 2018 |
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)
- Atacand Hct
- Generic name (nonproprietary)
- candesartan cilexetil and hydrochlorothiazide
- Active ingredients
- Candesartan cilexetil — 16 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021093
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 62559-650_512f014c-894d-43ff-96a6-1ff05bc476e6SPL ID 512f014c-894d-43ff-96a6-1ff05bc476e6SPL set ID d91152c4-66ba-466f-b4f9-0da628d42b1dRxCUI 578325, 578330, 802749, 805855, 805859, 805863UNII 0J48LPH2TH, R85M2X0D68UPC 0362559652902, 0362559651905, 0362559650908
- 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
N462559065090followed by a unit qualifier and the quantityPackage 62559-0650-90. 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)
INDICATIONS AND USAGE ATACAND HCT is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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 ATACAND HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation,…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021093
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 |
|---|---|---|---|---|
| Atacand Hctcandesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-651 |
| Atacand Hctcandesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-652 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-660 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-661 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-662 |
- openFDA data updated
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