FDA.reportPublic FDA data

TOPROL

Product NDC
70347-050
11-digit product format
703470050
Labeler code
70347
Product ID
70347-050_281e1868-3ef6-49a4-b228-97289bf39aaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aralez Pharmaceuticals US Inc.
Application
NDA019962
Marketing category
NDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70347-050-022025-01-30C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-032025-01-30C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-012021-02-10C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-022021-02-10C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-032021-02-10C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-012021-01-29C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-022021-01-29C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-050-032021-01-29C16284748780-1ba0f9c33-3eaf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70347-050-02TOPROLXL100 in 1 BOTTLETABLET, EXTENDED RELEASE10020
70347-050-03TOPROLXL1000 in 1 BOTTLETABLET, EXTENDED RELEASE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70347-050-02EA - Each70347-0505d37b197-0ed0-4a03-be8c-4092ef21efe612018-01-12
70347-050-03EA - Each70347-050b159ee78-37d6-499c-b54e-b67daa1fc8fe12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70347-050TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [ARALEZ PHARMACEUTICALS US INC.]20Legacy NDC, 2 package rows20230425_991fe00b-498b-400e-9e5b-921cb07d9b2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866414Toprol XL 100 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866421Toprol XL 200 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866429Toprol XL 25 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
866438Toprol XL 50 MG 24HR Extended Release Oral TabletPSN991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641424 HR metoprolol succinate 100 MG Extended Release Oral Tablet [Toprol]SBD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642124 HR metoprolol succinate 200 MG Extended Release Oral Tablet [Toprol]SBD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642924 HR metoprolol succinate 25 MG Extended Release Oral Tablet [Toprol]SBD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86643824 HR metoprolol succinate 50 MG Extended Release Oral Tablet [Toprol]SBD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641424 HR Toprol 100 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642124 HR Toprol 200 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642924 HR Toprol 25 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86643824 HR Toprol 50 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86641424 HR Toprol XL 100 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642124 HR Toprol XL 200 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
86642924 HR Toprol XL 25 MG Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866414Toprol XL (metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866421Toprol XL (metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866429Toprol XL (metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866438Toprol XL (metoprolol succinate 50 MG (as metoprolol succinate 49.5 MG equivalent to 500 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866414Toprol XL 100 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866421Toprol XL 200 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866429Toprol XL 25 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20
866438Toprol XL 50 MG 24 HR Extended Release Oral TabletSY991fe00b-498b-400e-9e5b-921cb07d9b2c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70347-050-017034700500130 TABLET, EXTENDED RELEASE in 1 BOTTLE (70347-050-01) 2018-01-010000-00-00NoNoCurrent
70347-050-0270347005002100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70347-050-02) 2018-01-010000-00-00NoNoCurrent
70347-050-03703470050031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70347-050-03) 2018-01-010000-00-00NoNoCurrent