Prescription drug · ANDA
Candesartan NDC 71335-3032
Candesartan cilexetil 16 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-3032-1 | 71335303201 | 30 TABLET in 1 BOTTLE (71335-3032-1)Marketed from Feb 5, 2026 | |
| 71335-3032-2 | 71335303202 | 90 TABLET in 1 BOTTLE (71335-3032-2)Marketed from Feb 5, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- candesartan
- Active ingredients
- Candesartan cilexetil — 16 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203813
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-3032_eeef5a15-6a83-4012-aee3-486668b243a2SPL ID eeef5a15-6a83-4012-aee3-486668b243a2SPL set ID 7eb297cb-ef1b-44e0-a49d-03727100579eRxCUI 577776UNII R85M2X0D68
- 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
N471335303201followed by a unit qualifier and the quantityPackage 71335-3032-01. 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 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 non-fatal car…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203813
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 | Candesartan cilexetil 16 mg/1 | TabletOral | NorthStar RxLLC | 72603-720 |
| Candesartan | Candesartan cilexetil 32 mg/1 | TabletOral | NorthStar RxLLC | 72603-721 |
| Candesartan | Candesartan cilexetil 4 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-114 |
| Candesartan | Candesartan cilexetil 8 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-115 |
| Candesartan | Candesartan cilexetil 16 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-116 |
| Candesartan | Candesartan cilexetil 32 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-117 |