Prescription drug · ANDA
Candesartan Cilexetil and Hydrochlorothiazide NDC 33342-132
Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-132-10 | 33342013210 | 90 TABLET in 1 BOTTLE (33342-132-10)Marketed from Mar 7, 2015 | |
| 33342-132-12 | 33342013212 | 10 BLISTER PACK in 1 CARTON (33342-132-12) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 7, 2015 | |
| 33342-132-15 | 33342013215 | 500 TABLET in 1 BOTTLE (33342-132-15)Marketed from Mar 7, 2015 | |
| 33342-132-51 | 33342013251 | 300 TABLET in 1 BOTTLE (33342-132-51)Marketed from Mar 7, 2015 |
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 and Hydrochlorothiazide
- Generic name (nonproprietary)
- candesartan cilexetil and hydrochlorothiazide
- Active ingredients
- Candesartan cilexetil — 32 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204100
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 33342-132_07873250-a90d-4e06-bfa8-a4202794791dSPL ID 07873250-a90d-4e06-bfa8-a4202794791dSPL set ID 76630807-9717-44be-946d-756038cf677eRxCUI 578325, 578330, 802749UNII 0J48LPH2TH, R85M2X0D68UPC 0333342131515, 0333342131102, 0333342133106, 0333342132109
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
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
N433342013210followed by a unit qualifier and the quantityPackage 33342-0132-10. 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)
INDICATIONS & USAGE Candesartan cilexitil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexitil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204100
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 and Hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-131 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-133 |