fosinopril sodium and hydrochlorothiazide (69097-972)

Drug Facts

Product Profile

Brand Name fosinopril sodium and hydrochlorothiazide

Generic Name fosinopril sodium and hydrochlorothiazide

Labeler cipla usa inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

fosinopril sodium 10 mg/1, hydrochlorothiazide 12.5 mg/1

Manufacturer

CIPLA USA INC.

Identifiers & Regulatory

Product NDC 69097-972

Product ID 69097-972_25e66ad5-947a-4262-a996-a9695601d301

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090228

Listing Expiration 2026-12-31

Marketing Start 2020-07-24

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 69097972

Hyphenated Format 69097-972

Supplemental Identifiers

RxCUI

857166 857174

UPC

0369097973070 0369097972073

UNII

0J48LPH2TH NW2RTH6T2N

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 fosinopril sodium and hydrochlorothiazide (source: ndc)

Generic Name fosinopril sodium and hydrochlorothiazide (source: ndc)

Application Number ANDA090228 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
12.5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (69097-972-07)

source: ndc

Packages (1)

69097-972-07 100 TABLET in 1 BOTTLE (69097-972-07)

Ingredients (2)

fosinopril sodium (10 mg/1) hydrochlorothiazide (12.5 mg/1)

Linked Drug Pages (1)

Fosinopril Sodium and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "25e66ad5-947a-4262-a996-a9695601d301", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0369097973070", "0369097972073"], "unii": ["0J48LPH2TH", "NW2RTH6T2N"], "rxcui": ["857166", "857174"], "spl_set_id": ["4e1ed7da-029e-48d6-a5e4-fc7ac11192fb"], "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": "100 TABLET in 1 BOTTLE (69097-972-07)", "package_ndc": "69097-972-07", "marketing_start_date": "20200724"}], "brand_name": "Fosinopril Sodium and Hydrochlorothiazide", "product_id": "69097-972_25e66ad5-947a-4262-a996-a9695601d301", "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": "69097-972", "generic_name": "Fosinopril Sodium and Hydrochlorothiazide", "labeler_name": "CIPLA USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosinopril Sodium and Hydrochlorothiazide", "active_ingredients": [{"name": "FOSINOPRIL SODIUM", "strength": "10 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA090228", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20261231"}