metoprolol tartrate and hydrochlorothiazide (46708-115)

Drug Facts

Product Profile

Brand Name metoprolol tartrate and hydrochlorothiazide

Generic Name metoprolol tartrate and hydrochlorothiazide

Labeler alembic pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-115

Product ID 46708-115_5afb35ed-f222-47c7-ac02-3b1d062b09d2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202870

Listing Expiration 2026-12-31

Marketing Start 2013-09-17

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 46708115

Hyphenated Format 46708-115

Supplemental Identifiers

RxCUI

866479 866482 866491

UPC

0346708115302 0346708116309 0346708117306

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 ANDA202870 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
50 mg/1

source: ndc

Packaging

1000 TABLET in 1 BOTTLE (46708-115-01)
100 TABLET in 1 BOTTLE (46708-115-10)
30 TABLET in 1 BOTTLE (46708-115-30)

source: ndc

Packages (3)

46708-115-01 1000 TABLET in 1 BOTTLE (46708-115-01) 46708-115-10 100 TABLET in 1 BOTTLE (46708-115-10) 46708-115-30 30 TABLET in 1 BOTTLE (46708-115-30)

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": "5afb35ed-f222-47c7-ac02-3b1d062b09d2", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0346708115302", "0346708116309", "0346708117306"], "unii": ["0J48LPH2TH", "W5S57Y3A5L"], "rxcui": ["866479", "866482", "866491"], "spl_set_id": ["538ea34a-1ac3-48c8-b841-43be09285e12"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-115-01)", "package_ndc": "46708-115-01", "marketing_start_date": "20130917"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-115-10)", "package_ndc": "46708-115-10", "marketing_start_date": "20130917"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-115-30)", "package_ndc": "46708-115-30", "marketing_start_date": "20130917"}], "brand_name": "Metoprolol Tartrate and Hydrochlorothiazide", "product_id": "46708-115_5afb35ed-f222-47c7-ac02-3b1d062b09d2", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "46708-115", "generic_name": "Metoprolol Tartrate and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "ANDA202870", "marketing_category": "ANDA", "marketing_start_date": "20130917", "listing_expiration_date": "20261231"}