fosinopril sodium and hydrochlorothiazide

Generic: fosinopril sodium and hydrochlorothiazide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosinopril sodium and hydrochlorothiazide
Generic Name fosinopril sodium and hydrochlorothiazide
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fosinopril sodium 20 mg/1, hydrochlorothiazide 12.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-309
Product ID 65862-309_34bf0456-37d0-4d7d-a585-1555b7bc9373
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079245
Listing Expiration 2026-12-31
Marketing Start 2009-07-09

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 65862309
Hyphenated Format 65862-309

Supplemental Identifiers

RxCUI
857166 857174
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 ANDA079245 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-309-01)
  • 30 TABLET in 1 BOTTLE (65862-309-30)
  • 1000 TABLET in 1 BOTTLE (65862-309-99)
source: ndc

Packages (3)

65862-309-01 100 TABLET in 1 BOTTLE (65862-309-01) 65862-309-30 30 TABLET in 1 BOTTLE (65862-309-30) 65862-309-99 1000 TABLET in 1 BOTTLE (65862-309-99)

Ingredients (2)

fosinopril sodium (20 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": "34bf0456-37d0-4d7d-a585-1555b7bc9373", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "NW2RTH6T2N"], "rxcui": ["857166", "857174"], "spl_set_id": ["35019655-9a30-4305-a262-936ad0e73071"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-309-01)", "package_ndc": "65862-309-01", "marketing_start_date": "20090709"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-309-30)", "package_ndc": "65862-309-30", "marketing_start_date": "20090709"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-309-99)", "package_ndc": "65862-309-99", "marketing_start_date": "20090709"}], "brand_name": "Fosinopril Sodium and Hydrochlorothiazide", "product_id": "65862-309_34bf0456-37d0-4d7d-a585-1555b7bc9373", "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": "65862-309", "generic_name": "Fosinopril Sodium and Hydrochlorothiazide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosinopril Sodium and Hydrochlorothiazide", "active_ingredients": [{"name": "FOSINOPRIL SODIUM", "strength": "20 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA079245", "marketing_category": "ANDA", "marketing_start_date": "20090709", "listing_expiration_date": "20261231"}