lisinopril and hydrochlorothiazide (69097-971)

Drug Facts

Product Profile

Brand Name lisinopril and hydrochlorothiazide

Generic Name lisinopril and hydrochlorothiazide tablets

Labeler cipla usa inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, lisinopril 20 mg/1

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-971

Product ID 69097-971_2815b0ef-9835-4b49-b98d-8519e7005dc1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204058

Listing Expiration 2026-12-31

Marketing Start 2019-12-26

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097971

Hyphenated Format 69097-971

Supplemental Identifiers

RxCUI

197885 197886 197887

UPC

0369097971076 0369097969073 0369097968076

UNII

0J48LPH2TH E7199S1YWR

NUI

N0000175359 N0000175419 M0471776

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lisinopril and hydrochlorothiazide (source: ndc)

Generic Name lisinopril and hydrochlorothiazide tablets (source: ndc)

Application Number ANDA204058 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
20 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (69097-971-05)
100 TABLET in 1 BOTTLE (69097-971-07)
500 TABLET in 1 BOTTLE (69097-971-12)
1000 TABLET in 1 BOTTLE (69097-971-15)

source: ndc

Packages (4)

69097-971-05 90 TABLET in 1 BOTTLE (69097-971-05) 69097-971-07 100 TABLET in 1 BOTTLE (69097-971-07) 69097-971-12 500 TABLET in 1 BOTTLE (69097-971-12) 69097-971-15 1000 TABLET in 1 BOTTLE (69097-971-15)

Ingredients (2)

hydrochlorothiazide (25 mg/1) lisinopril (20 mg/1)

Linked Drug Pages (1)

Lisinopril and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2815b0ef-9835-4b49-b98d-8519e7005dc1", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0369097971076", "0369097969073", "0369097968076"], "unii": ["0J48LPH2TH", "E7199S1YWR"], "rxcui": ["197885", "197886", "197887"], "spl_set_id": ["40e6b627-63dc-4d52-aaa8-750663ad86c2"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (69097-971-05)", "package_ndc": "69097-971-05", "marketing_start_date": "20191226"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-971-07)", "package_ndc": "69097-971-07", "marketing_start_date": "20191226"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-971-12)", "package_ndc": "69097-971-12", "marketing_start_date": "20191226"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69097-971-15)", "package_ndc": "69097-971-15", "marketing_start_date": "20191226"}], "brand_name": "Lisinopril and Hydrochlorothiazide", "product_id": "69097-971_2815b0ef-9835-4b49-b98d-8519e7005dc1", "dosage_form": "TABLET", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "69097-971", "generic_name": "Lisinopril and Hydrochlorothiazide Tablets", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisinopril and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "LISINOPRIL", "strength": "20 mg/1"}], "application_number": "ANDA204058", "marketing_category": "ANDA", "marketing_start_date": "20191226", "listing_expiration_date": "20261231"}