metoprolol tartrate and hydrochlorothiazide

Generic: metoprolol tartrate and hydrochlorothiazide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metoprolol tartrate and hydrochlorothiazide
Generic Name metoprolol tartrate and hydrochlorothiazide
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, metoprolol tartrate 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-368
Product ID 62756-368_99595af6-8c5d-4dc7-8396-e7bce050bb3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090654
Listing Expiration 2026-12-31
Marketing Start 2022-04-01

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 62756368
Hyphenated Format 62756-368

Supplemental Identifiers

RxCUI
866479 866482 866491
UPC
0362756368880 0362756369887 0362756370883
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 ANDA090654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62756-368-08)
  • 1000 TABLET in 1 BOTTLE (62756-368-18)
  • 30 TABLET in 1 BOTTLE (62756-368-83)
  • 100 TABLET in 1 BOTTLE (62756-368-88)
source: ndc

Packages (4)

62756-368-08 100 TABLET in 1 BOTTLE (62756-368-08) 62756-368-18 1000 TABLET in 1 BOTTLE (62756-368-18) 62756-368-83 30 TABLET in 1 BOTTLE (62756-368-83) 62756-368-88 100 TABLET in 1 BOTTLE (62756-368-88)

Ingredients (2)

hydrochlorothiazide (25 mg/1) metoprolol tartrate (100 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": "99595af6-8c5d-4dc7-8396-e7bce050bb3f", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0362756368880", "0362756369887", "0362756370883"], "unii": ["0J48LPH2TH", "W5S57Y3A5L"], "rxcui": ["866479", "866482", "866491"], "spl_set_id": ["faaf13ce-5d8d-4c57-a49f-a7a73daa41a5"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62756-368-08)", "package_ndc": "62756-368-08", "marketing_start_date": "20220401"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62756-368-18)", "package_ndc": "62756-368-18", "marketing_start_date": "20220401"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62756-368-83)", "package_ndc": "62756-368-83", "marketing_start_date": "20220401"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (62756-368-88)", "package_ndc": "62756-368-88", "marketing_start_date": "20220401"}], "brand_name": "Metoprolol Tartrate and Hydrochlorothiazide", "product_id": "62756-368_99595af6-8c5d-4dc7-8396-e7bce050bb3f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "62756-368", "generic_name": "Metoprolol Tartrate and Hydrochlorothiazide", "labeler_name": "Sun Pharmaceutical Industries, 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": "100 mg/1"}], "application_number": "ANDA090654", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}