lisinopril and hydrochlorothiazide

Generic: lisinopril and hydrochlorothiazide tablets

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisinopril and hydrochlorothiazide
Generic Name lisinopril and hydrochlorothiazide tablets
Labeler exelan pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, lisinopril 20 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-447
Product ID 76282-447_7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c
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 76282447
Hyphenated Format 76282-447

Supplemental Identifiers

RxCUI
197885 197886 197887
UPC
0376282448909 0376282447902 0376282446905
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
  • 12.5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76282-447-01)
  • 500 TABLET in 1 BOTTLE (76282-447-05)
  • 1000 TABLET in 1 BOTTLE (76282-447-10)
  • 90 TABLET in 1 BOTTLE (76282-447-90)
source: ndc

Packages (4)

76282-447-01 100 TABLET in 1 BOTTLE (76282-447-01) 76282-447-05 500 TABLET in 1 BOTTLE (76282-447-05) 76282-447-10 1000 TABLET in 1 BOTTLE (76282-447-10) 76282-447-90 90 TABLET in 1 BOTTLE (76282-447-90)

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": "7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0376282448909", "0376282447902", "0376282446905"], "unii": ["0J48LPH2TH", "E7199S1YWR"], "rxcui": ["197885", "197886", "197887"], "spl_set_id": ["c40b15ec-6083-4778-bca8-3e895e5694e1"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76282-447-01)", "package_ndc": "76282-447-01", "marketing_start_date": "20190501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76282-447-05)", "package_ndc": "76282-447-05", "marketing_start_date": "20190501"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76282-447-10)", "package_ndc": "76282-447-10", "marketing_start_date": "20190501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76282-447-90)", "package_ndc": "76282-447-90", "marketing_start_date": "20190501"}], "brand_name": "Lisinopril and Hydrochlorothiazide", "product_id": "76282-447_7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c", "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": "76282-447", "generic_name": "Lisinopril and Hydrochlorothiazide Tablets", "labeler_name": "Exelan Pharmaceuticals, Inc.", "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": "ANDA204058", "marketing_category": "ANDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}