Quinapril HCL and Hydrochlorothiazide NDC 43386-711

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-711Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0711Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43386-711-05	43386071105	500 TABLET in 1 BOTTLE (43386-711-05)Marketed from Jul 15, 2011
43386-711-09	43386071109	90 TABLET in 1 BOTTLE (43386-711-09)Marketed from Jul 15, 2011

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 HCL and Hydrochlorothiazide
Generic name (nonproprietary): quinapril hcl and hydrochlorothiazide
Active ingredients: Quinapril hydrochloride — 20 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076374
Marketing start: Jul 15, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 43386-711_916f3e69-0d6e-4524-8abe-afb2e134eec2SPL ID 916f3e69-0d6e-4524-8abe-afb2e134eec2SPL set ID 383ecaa6-29c8-4280-a442-c47f101d7c88RxCUI 310796, 310797, 310809UNII 33067B3N2M, 0J48LPH2TH
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

N443386071105 followed by a unit qualifier and the quantity

Package 43386-0711-05. 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 Jan 30, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hypertension : Quinapril and Hydrochlorothiazide Tablets is 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, lipi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076374

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076374
Product	Strength	Form · route	Labeler	Product NDC
Quinapril HCL and Hydrochlorothiazide	Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-712
Quinapril HCL and Hydrochlorothiazide	Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-710
Quinapril and Hydrochlorothiazide	Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Chartwell RX, LLC	62135-669
Quinapril and Hydrochlorothiazide	Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Chartwell RX, LLC	62135-667
Quinapril and Hydrochlorothiazide	Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Chartwell RX, LLC	62135-668