spironolactone and hydrochlorothiazide (0378-0403)

Drug Facts

Product Profile

Brand Name spironolactone and hydrochlorothiazide

Generic Name spironolactone and hydrochlorothiazide

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, spironolactone 25 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0403

Product ID 0378-0403_84d6af55-41ae-41f3-b683-4c72c26338fc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA086513

Listing Expiration 2027-12-31

Marketing Start 1979-08-03

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] aldosterone antagonist [epc]

Mechanism of Action

aldosterone antagonists [moa]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780403

Hyphenated Format 0378-0403

Supplemental Identifiers

RxCUI

198224

UNII

0J48LPH2TH 27O7W4T232

NUI

N0000175359 N0000175419 M0471776 N0000175557 N0000011310

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 spironolactone and hydrochlorothiazide (source: ndc)

Generic Name spironolactone and hydrochlorothiazide (source: ndc)

Application Number ANDA086513 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)
500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05)

source: ndc

Packages (2)

0378-0403-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01) 0378-0403-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05)

Ingredients (2)

hydrochlorothiazide (25 mg/1) spironolactone (25 mg/1)

Linked Drug Pages (1)

Spironolactone and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "84d6af55-41ae-41f3-b683-4c72c26338fc", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000175557", "N0000011310"], "unii": ["0J48LPH2TH", "27O7W4T232"], "rxcui": ["198224"], "spl_set_id": ["0c8c973f-13a2-4883-8316-4006398e2931"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)", "package_ndc": "0378-0403-01", "marketing_start_date": "19790803"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05)", "package_ndc": "0378-0403-05", "marketing_start_date": "19790803"}], "brand_name": "Spironolactone and Hydrochlorothiazide", "product_id": "0378-0403_84d6af55-41ae-41f3-b683-4c72c26338fc", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0378-0403", "generic_name": "spironolactone and hydrochlorothiazide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA086513", "marketing_category": "ANDA", "marketing_start_date": "19790803", "listing_expiration_date": "20271231"}