Prescription drug · NDA
Atacand (candesartan cilexetil) NDC 62559-640
Candesartan cilexetil 4 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-640-30 | 62559064030 | 30 TABLET in 1 BOTTLE (62559-640-30)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
- Generic name (nonproprietary)
- candesartan cilexetil
- Active ingredients
- Candesartan cilexetil — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020838
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62559-640_6ae461eb-f06a-4bf1-b6da-73d66b99b33cSPL ID 6ae461eb-f06a-4bf1-b6da-73d66b99b33cSPL set ID 94a59260-d2b6-464a-b5b9-bbc599e57e10RxCUI 153822, 153823, 577776, 577785, 577787, 639537, 639539, 639543UNII R85M2X0D68UPC 0362559643306, 0362559642309, 0362559640305, 0362559641302
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
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
N462559064030followed by a unit qualifier and the quantityPackage 62559-0640-30. 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)
ATACAND is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) . • Treatment of heart failure (NYHA class II-IV); ATACAND reduces cardiovascular death and heart failure hospitalization (1.2) . 1.1 Hypertension ATACAND is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020838
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 |
|---|---|---|---|---|
| Atacandcandesartan cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-641 |
| Atacandcandesartan cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-642 |
| Atacandcandesartan cilexetil | Candesartan cilexetil 32 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-643 |
| Candesartan cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-686 |
| Candesartan cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-687 |
| Candesartan cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-688 |
| Candesartan cilexetil | Candesartan cilexetil 32 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-689 |
| Candesartan cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-882 |
| Candesartan cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-883 |
| Candesartan cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-884 |
| Candesartan cilexetil | Candesartan cilexetil 32 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-885 |