metoprolol tartrate and hydrochlorothiazide (0378-0424)

Drug Facts

Product Profile

Brand Name metoprolol tartrate and hydrochlorothiazide

Generic Name metoprolol tartrate and hydrochlorothiazide

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, metoprolol tartrate 50 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0424

Product ID 0378-0424_771d61ce-0810-4998-b77b-9d3fe58056d9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076792

Listing Expiration 2026-12-31

Marketing Start 2004-08-20

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 03780424

Hyphenated Format 0378-0424

Supplemental Identifiers

RxCUI

866479 866482 866491

UPC

0303780434011 0303780424012 0303780445017

UNII

0J48LPH2TH W5S57Y3A5L

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 metoprolol tartrate and hydrochlorothiazide (source: ndc)

Generic Name metoprolol tartrate and hydrochlorothiazide (source: ndc)

Application Number ANDA076792 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
50 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (0378-0424-01)

source: ndc

Packages (1)

0378-0424-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0424-01)

Ingredients (2)

hydrochlorothiazide (25 mg/1) metoprolol tartrate (50 mg/1)

Linked Drug Pages (1)

Metoprolol Tartrate and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "771d61ce-0810-4998-b77b-9d3fe58056d9", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0303780434011", "0303780424012", "0303780445017"], "unii": ["0J48LPH2TH", "W5S57Y3A5L"], "rxcui": ["866479", "866482", "866491"], "spl_set_id": ["b6cf0f43-8dc3-4535-b651-daf1f9e0336c"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0424-01)", "package_ndc": "0378-0424-01", "marketing_start_date": "20040820"}], "brand_name": "Metoprolol Tartrate and Hydrochlorothiazide", "product_id": "0378-0424_771d61ce-0810-4998-b77b-9d3fe58056d9", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0378-0424", "generic_name": "metoprolol tartrate and hydrochlorothiazide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metoprolol Tartrate and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "METOPROLOL TARTRATE", "strength": "50 mg/1"}], "application_number": "ANDA076792", "marketing_category": "ANDA", "marketing_start_date": "20040820", "listing_expiration_date": "20261231"}