Dutoprol

Product NDC: 59212-095
11-digit product format: 592120095
Labeler code: 59212
Product ID: 59212-095_ab789dec-c39e-4dcf-9e51-618cc239dafc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoprolol succinate and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Concordia Pharmaceuticals Inc.
Application: NDA021956
Marketing category: NDA
Marketing start: 2014-07-01
Marketing end: 2022-09-30
Substance: HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
Active strength: 13 mg/1; mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59212-095-30	EA - Each	59212-095	9f230610-26cb-453f-88d5-9313ba41e08d	1	2016-02-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
TH25PD4CCB	METOPROLOL SUCCINATE	98418-47-4	METOPROLOL SUCCINATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59212-095-30	59212009530	30 TABLET in 1 BOTTLE (59212-095-30)	30 tablet	2014-07-01	2022-09-30	No	No	Current