Prescription drug · ANDA
Candesartan NDC 33342-115
Candesartan cilexetil 8 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-115-07 | 3334201150733342011507 | 30 TABLET in 1 CONTAINER (33342-115-07)Marketed from Dec 6, 2016 | |
| 33342-115-10 | 3334201151033342011510 | 90 TABLET in 1 CONTAINER (33342-115-10)Marketed from Dec 6, 2016 | |
| 33342-115-12 | 3334201151233342011512 | 10 BLISTER PACK in 1 CARTON (33342-115-12) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 6, 2016 | |
| 33342-115-51 | 3334201155133342011551 | 300 TABLET in 1 CONTAINER (33342-115-51)Marketed from Dec 6, 2016 |
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
- Generic name (nonproprietary)
- candesartan
- Active ingredients
- Candesartan cilexetil — 8 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- 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 33342-115_4079c843-42ee-4f7a-a4a0-9498ba6cf12dSPL ID 4079c843-42ee-4f7a-a4a0-9498ba6cf12dSPL set ID 8ceb5658-b03c-475d-9ef0-2cd0645191d3RxCUI 153822, 153823, 577776, 639537UNII R85M2X0D68UPC 0333342117106, 0333342116109, 0333342114105, 0333342114075, 0333342116079, 0333342117076, 0333342115072, 0333342114129, 0333342115102, 0333342117120, 0333342115126, 0333342116123
- 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
N433342011507followed by a unit qualifier and the quantityPackage 33342-0115-07. 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.
About NDC 33342-115
- What is NDC 33342-115?
- 33342-115 is the product NDC for Candesartan, Candesartan cilexetil 8 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Candesartan.
- What is the active ingredient?
- Candesartan cilexetil.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?
- 6 other product NDCs are listed under this name. See all Candesartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Candesartan 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 | Candesartan cilexetil 16 mg/1 | TabletOral | NorthStar RxLLC | 72603-720 | 72603-0720-01 |
| Candesartan | Candesartan cilexetil 32 mg/1 | TabletOral | NorthStar RxLLC | 72603-721 | 72603-0721-01 |
| Candesartan | Candesartan cilexetil 4 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-114 | 33342-0114-0733342-0114-1033342-0114-12+1 more |
| Candesartan | Candesartan cilexetil 16 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-116 | 33342-0116-0733342-0116-1033342-0116-12+1 more |
| Candesartan | Candesartan cilexetil 32 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-117 | 33342-0117-0733342-0117-1033342-0117-12+1 more |
| Candesartan | Candesartan cilexetil 16 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3032 | 71335-3032-0171335-3032-02 |
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 4 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-114 |
| Candesartan | Candesartan cilexetil 16 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-116 |
| Candesartan | Candesartan cilexetil 32 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-117 |
| Candesartan | Candesartan cilexetil 16 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3032 |
| Candesartan | Candesartan cilexetil 16 mg/1 | TabletOral | NorthStar RxLLC | 72603-720 |
| Candesartan | Candesartan cilexetil 32 mg/1 | TabletOral | NorthStar RxLLC | 72603-721 |