lisinopril and hydrochlorothiazide (71610-382)

Drug Facts

Product Profile

Brand Name lisinopril and hydrochlorothiazide

Generic Name lisinopril and hydrochlorothiazide tablets

Labeler aphena pharma solutions - tennessee, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, lisinopril 10 mg/1

Manufacturer

Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-382

Product ID 71610-382_29eb83f5-d92a-4b6f-acf6-3deecf7c4f9f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204058

Listing Expiration 2026-12-31

Marketing Start 2019-05-01

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 71610382

Hyphenated Format 71610-382

Supplemental Identifiers

RxCUI

197885 197886 197887

UNII

0J48LPH2TH E7199S1YWR

NUI

N0000175359 N0000175419 M0471776

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

12.5 mg/1
10 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (71610-382-30)
90 TABLET in 1 BOTTLE (71610-382-60)

source: ndc

Packages (2)

71610-382-30 30 TABLET in 1 BOTTLE (71610-382-30) 71610-382-60 90 TABLET in 1 BOTTLE (71610-382-60)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) lisinopril (10 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": "29eb83f5-d92a-4b6f-acf6-3deecf7c4f9f", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "E7199S1YWR"], "rxcui": ["197885", "197886", "197887"], "spl_set_id": ["e2903227-4a79-4a9c-b96b-073b8e41fb01"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-382-30)", "package_ndc": "71610-382-30", "marketing_start_date": "20200110"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-382-60)", "package_ndc": "71610-382-60", "marketing_start_date": "20200110"}], "brand_name": "Lisinopril and Hydrochlorothiazide", "product_id": "71610-382_29eb83f5-d92a-4b6f-acf6-3deecf7c4f9f", "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": "71610-382", "generic_name": "Lisinopril and Hydrochlorothiazide Tablets", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisinopril and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "LISINOPRIL", "strength": "10 mg/1"}], "application_number": "ANDA204058", "marketing_category": "ANDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}