Prescription drug · ANDA
Candesartan Cilexetil and Hydrochlorothiazide NDC 0378-3001
Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3001-77 | 0037830017700378300177 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77)Marketed from Dec 4, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090704
- Marketing start
- Marketing end
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 0378-3001_b308024b-d9c2-4b12-ac28-cb2e295ab1bfSPL ID b308024b-d9c2-4b12-ac28-cb2e295ab1bfSPL set ID f3c4f7ed-e667-4528-a675-b032c2a4425dRxCUI 578325, 578330, 802749UNII R85M2X0D68, 0J48LPH2THUPC 0303783003771, 0303783001777, 0303783002774
- 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
N400378300177followed by a unit qualifier and the quantityPackage 00378-3001-77. 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 0378-3001
- What is NDC 0378-3001?
- 0378-3001 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 Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-459 | 43547-0459-0943547-0459-50 |
| 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 |