lisinopril and hydrochlorothiazide

Generic: lisinopril and hydrochlorothiazide

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisinopril and hydrochlorothiazide
Generic Name lisinopril and hydrochlorothiazide
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, lisinopril 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-838
Product ID 71610-838_1a04bf5f-b08a-02b4-e063-6294a90ac472
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077912
Listing Expiration 2026-12-31
Marketing Start 2006-10-04

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 71610838
Hyphenated Format 71610-838

Supplemental Identifiers

RxCUI
197886
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 (source: ndc)
Application Number ANDA077912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-838-30)
  • 60 TABLET in 1 BOTTLE (71610-838-53)
  • 90 TABLET in 1 BOTTLE (71610-838-60)
  • 120 TABLET in 1 BOTTLE (71610-838-70)
  • 180 TABLET in 1 BOTTLE (71610-838-80)
source: ndc

Packages (5)

71610-838-30 30 TABLET in 1 BOTTLE (71610-838-30) 71610-838-53 60 TABLET in 1 BOTTLE (71610-838-53) 71610-838-60 90 TABLET in 1 BOTTLE (71610-838-60) 71610-838-70 120 TABLET in 1 BOTTLE (71610-838-70) 71610-838-80 180 TABLET in 1 BOTTLE (71610-838-80)

Ingredients (2)

hydrochlorothiazide (12.5 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": "1a04bf5f-b08a-02b4-e063-6294a90ac472", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "E7199S1YWR"], "rxcui": ["197886"], "spl_set_id": ["1a04bf47-07fb-ed32-e063-6294a90a07cc"], "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 (71610-838-30)", "package_ndc": "71610-838-30", "marketing_start_date": "20240531"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-838-53)", "package_ndc": "71610-838-53", "marketing_start_date": "20240531"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-838-60)", "package_ndc": "71610-838-60", "marketing_start_date": "20240531"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-838-70)", "package_ndc": "71610-838-70", "marketing_start_date": "20240531"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-838-80)", "package_ndc": "71610-838-80", "marketing_start_date": "20240531"}], "brand_name": "Lisinopril and Hydrochlorothiazide", "product_id": "71610-838_1a04bf5f-b08a-02b4-e063-6294a90ac472", "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": "71610-838", "generic_name": "Lisinopril and Hydrochlorothiazide", "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": "20 mg/1"}], "application_number": "ANDA077912", "marketing_category": "ANDA", "marketing_start_date": "20061004", "listing_expiration_date": "20261231"}