Prescription drug · ANDA
Candesartan Cilexetil NDC 46708-343
Candesartan cilexetil 16 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-343-30 | 46708034330 | 30 TABLET in 1 BOTTLE (46708-343-30)Marketed from Dec 5, 2018 | |
| 46708-343-90 | 46708034390 | 90 TABLET in 1 BOTTLE (46708-343-90)Marketed from Dec 5, 2018 | |
| 46708-343-91 | 46708034391 | 1000 TABLET in 1 BOTTLE (46708-343-91)Marketed from Dec 5, 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)
- Candesartan Cilexetil
- Generic name (nonproprietary)
- candesartan cilexetil
- Active ingredients
- Candesartan cilexetil — 16 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210302
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-343_aaa63206-6c7d-4996-8991-91bfdb69b821SPL ID aaa63206-6c7d-4996-8991-91bfdb69b821SPL set ID d5b43fa0-6678-4219-99f1-10d273d49bafRxCUI 153822, 153823, 577776UNII R85M2X0D68UPC 0346708341305, 0346708342302, 0346708343309
- 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
N446708034330followed by a unit qualifier and the quantityPackage 46708-0343-30. 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)
Candesartan cilexetil tablets are 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); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization (1.2). 1.1 Hypertension Candesartan cilexetil tablets are 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210302
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 |
|---|---|---|---|---|
| Candesartan Cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9842 |
| Candesartan Cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-341 |
| Candesartan Cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-342 |
| Candesartan Cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-341 |
| Candesartan Cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-342 |
| Candesartan Cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-343 |