NDC 59212-095

Dutoprol

Metoprolol Succinate And Hydrochlorothiazide

Dutoprol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is Metoprolol Succinate; Hydrochlorothiazide.

• Product ID: 59212-095_0e298cf1-149a-46cc-8dd1-90c5bb4a0b77
• NDC: 59212-095
• Product Type: Human Prescription Drug
• Proprietary Name: Dutoprol
• Generic Name: Metoprolol Succinate And Hydrochlorothiazide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021956
• Labeler Name: Concordia Pharmaceuticals Inc.
• Substance Name: METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59212-095-30

30 TABLET in 1 BOTTLE (59212-095-30)

• Marketing Start Date: 2014-07-01
• Marketing End Date: 2022-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59212-095-30 [59212009530]

Dutoprol TABLET

• Marketing Category: NDA
• Application Number: NDA021956
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-01

Drug Details

Active Ingredients

Ingredient	Strength
METOPROLOL SUCCINATE	50 mg/1

OpenFDA Data

• SPL SET ID: 69ffe86d-7993-482d-b1bb-04287bdd6aa9
• Manufacturer:
  • Concordia Pharmaceuticals Inc.
• UNII:
  • TH25PD4CCB
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 866464
  • 866472
  • 866461
  • 866475
  • 866452
  • 866455
• UPC Code:
  • 0359212097309
  • 0359212095305
  • 0359212087300

Pharmacological Class

• Adrenergic beta-Antagonists [MoA]
• beta-Adrenergic Blocker [EPC]
• Increased Diuresis [PE]
• Thiazide Diuretic [EPC]
• Thiazides [CS]

NDC Crossover Matching brand name "Dutoprol" or generic name "Metoprolol Succinate And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
59212-087	Dutoprol	metoprolol succinate and hydrochlorothiazide
59212-095	Dutoprol	metoprolol succinate and hydrochlorothiazide
59212-097	Dutoprol	metoprolol succinate and hydrochlorothiazide
69499-321	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide
69499-323	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide
69499-324	metoprolol succinate and hydrochlorothiazide	metoprolol succinate and hydrochlorothiazide