What is NDC 69097-828?

69097-828 is the product NDC for Quinapril and Hydrochlorothiazide 10/12.5, Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Quinapril and Hydrochlorothiazide 10/12.5.

What is the active ingredient?

Quinapril hydrochloride, Hydrochlorothiazide.

Cipla USA Inc., NDC labeler code 69097. 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 and Hydrochlorothiazide 10/12.5?

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.

NDC 69097-828

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-828Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0828Add 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
69097-828-05	6909708280569097082805	90 TABLET in 1 BOTTLE (69097-828-05)Marketed from Jul 20, 2016

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 and Hydrochlorothiazide 10/12.5
Generic name (nonproprietary): quinapril and hydrochlorothiazide 10/12.5
Active ingredients: Quinapril hydrochloride — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201356
Marketing start: Jul 20, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 69097-828_4d3f7e7a-ed61-4df6-bc45-f38fb4117406SPL ID 4d3f7e7a-ed61-4df6-bc45-f38fb4117406SPL set ID 1de5420c-23d6-40c5-ba24-39143c0f90fbRxCUI 310796, 310797, 310809UNII 0J48LPH2TH, 33067B3N2MUPC 0369097831059, 0369097829056
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

N469097082805 followed by a unit qualifier and the quantity

Package 69097-0828-05. 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 7, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hypertension: Quinapril and hydrochlorothiazide tablets, USP 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,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-828

What is NDC 69097-828?: 69097-828 is the product NDC for Quinapril and Hydrochlorothiazide 10/12.5, Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Quinapril and Hydrochlorothiazide 10/12.5.
What is the active ingredient?: Quinapril hydrochloride, Hydrochlorothiazide.
Who is the labeler?: Cipla USA Inc., NDC labeler code 69097. 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 and Hydrochlorothiazide 10/12.5?: 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.

Other NDCs under ANDA 201356

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

FDA NDC Directory listings under ANDA 201356
Product	Strength	Form · route	Labeler	Product NDC
Quinapril and Hydrochlorothiazide 20/12.5	Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Cipla USA Inc.	69097-829
Quinapril and Hydrochlorothiazide 20/25	Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Cipla USA Inc.	69097-831

Quinapril and Hydrochlorothiazide 10/12.5 NDC 69097-828