Prescription drug · ANDA
candesartan cilexetil and hydrochlorothiazide NDC 43547-459
Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Solco Healthcare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-459-09 | 4354704590943547045909 | 90 TABLET in 1 BOTTLE (43547-459-09)Marketed from Nov 20, 2017 | |
| 43547-459-50 | 4354704595043547045950 | 500 TABLET in 1 BOTTLE (43547-459-50)Marketed from Nov 20, 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 and hydrochlorothiazide
- Generic name (nonproprietary)
- candesartan cilexetil and hydrochlorothiazide
- Active ingredients
- Candesartan cilexetil — 16 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207455
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 43547-459_745438ab-c3fe-4da9-9548-730970399e0dSPL ID 745438ab-c3fe-4da9-9548-730970399e0dSPL set ID 543b9806-ccfa-4144-a2a2-d0e35eaceeeeRxCUI 578325, 578330, 802749UNII 0J48LPH2TH, R85M2X0D68
- 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
N443547045909followed by a unit qualifier and the quantityPackage 43547-0459-09. 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 AND USAGE Candesartan cilexetil 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 cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as approp…
Excerpt only. Read the full label for complete information.
About NDC 43547-459
- What is NDC 43547-459?
- 43547-459 is the product NDC for candesartan cilexetil and hydrochlorothiazide, Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Solco Healthcare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- candesartan cilexetil and hydrochlorothiazide.
- What is the active ingredient?
- Candesartan cilexetil, Hydrochlorothiazide.
- Who is the labeler?
- Solco Healthcare LLC, NDC labeler code 43547. 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 and hydrochlorothiazide?
- 12 other product NDCs are listed under this name. See all candesartan cilexetil and hydrochlorothiazide 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 and hydrochlorothiazide 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 and Hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-660 | 62559-0660-90 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-661 | 62559-0661-90 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-662 | 62559-0662-90 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1325 | 70771-1325-0070771-1325-0170771-1325-03+2 more |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1326 | 70771-1326-0070771-1326-0170771-1326-03+2 more |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1327 | 70771-1327-0070771-1327-0170771-1327-03+2 more |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-460 | 43547-0460-0943547-0460-50 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Solco Healthcare LLC | 43547-461 | 43547-0461-0943547-0461-50 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-131 | 33342-0131-1033342-0131-1233342-0131-15+1 more |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-132 | 33342-0132-1033342-0132-1233342-0132-15+1 more |
Other NDCs under ANDA 207455
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 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-460 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Solco Healthcare LLC | 43547-461 |