Prescription drug · ANDA
Quinapril Hydrochloride/Hydrochlorothiazide NDC 65862-163
Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-163-90 | 6586201639065862016390 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-163-90)Marketed from Aug 24, 2007 |
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)
- Quinapril Hydrochloride/Hydrochlorothiazide
- Generic name (nonproprietary)
- quinapril hydrochloride/hydrochlorothiazide
- Active ingredients
- Quinapril hydrochloride — 20 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078450
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 65862-163_5842ecc2-874a-481b-8997-afa9d862dc5dSPL ID 5842ecc2-874a-481b-8997-afa9d862dc5dSPL set ID 50a58159-9572-4445-9859-b392632597daRxCUI 310796, 310797, 310809UNII 0J48LPH2TH, 33067B3N2MUPC 0365862161901
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; 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
N465862016390followed by a unit qualifier and the quantityPackage 65862-0163-90. 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 Hypertension Quinapril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 quinapril and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid…
Excerpt only. Read the full label for complete information.
About NDC 65862-163
- What is NDC 65862-163?
- 65862-163 is the product NDC for Quinapril Hydrochloride/Hydrochlorothiazide, Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinapril Hydrochloride/Hydrochlorothiazide.
- What is the active ingredient?
- Quinapril hydrochloride, Hydrochlorothiazide.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quinapril Hydrochloride/Hydrochlorothiazide?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.