Prescription drug · ANDA
Candesartan Cilexetil NDC 46708-060
Candesartan cilexetil 32 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-060-10 | 4670800601046708006010 | 100 TABLET in 1 CARTON (46708-060-10)Marketed from Jun 21, 2017 | |
| 46708-060-30 | 4670800603046708006030 | 30 TABLET in 1 BOTTLE (46708-060-30)Marketed from Jun 21, 2017 | |
| 46708-060-90 | 4670800609046708006090 | 90 TABLET in 1 BOTTLE (46708-060-90)Marketed from Jun 21, 2017 |
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 — 32 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209119
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-060_048b90e3-9511-49be-8513-ebd0bde1e03cSPL ID 048b90e3-9511-49be-8513-ebd0bde1e03cSPL set ID d23fe59a-2ad6-4885-a0d8-2239048f05a3RxCUI 639537UNII R85M2X0D68UPC 0346708060305
- 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
N446708006010followed by a unit qualifier and the quantityPackage 46708-0060-10. 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 n…
Excerpt only. Read the full label for complete information.
About NDC 46708-060
- What is NDC 46708-060?
- 46708-060 is the product NDC for Candesartan Cilexetil, Candesartan cilexetil 32 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Candesartan Cilexetil.
- What is the active ingredient?
- Candesartan cilexetil.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Candesartan Cilexetil?
- 28 other product NDCs are listed under this name. See all Candesartan Cilexetil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Candesartan Cilexetil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Candesartan cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-157 | 72578-0157-0672578-0157-16 |
| Candesartan cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-158 | 72578-0158-0672578-0158-16 |
| Candesartan cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-159 | 72578-0159-0672578-0159-16 |
| Candesartan cilexetil | Candesartan cilexetil 32 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-160 | 72578-0160-0672578-0160-16 |
| Candesartan cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-686 | 62559-0686-99 |
| Candesartan cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-687 | 62559-0687-99 |
| Candesartan cilexetil | Candesartan cilexetil 16 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-688 | 62559-0688-99 |
| Candesartan cilexetil | Candesartan cilexetil 32 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-689 | 62559-0689-98 |
| candesartan cilexetil | Candesartan cilexetil 4 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-3224 | 00378-3224-7700378-3224-93 |
| candesartan cilexetil | Candesartan cilexetil 8 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-3225 | 00378-3225-7700378-3225-93 |
Other NDCs under ANDA 209119
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 32 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-060 |