FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
68788-8255
11-digit product format
687888255
Labeler code
68788
Product ID
68788-8255_d8185d8c-a0ed-4cb8-af53-438b8e00e02e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078889
Marketing category
ANDA
Marketing start
2022-09-02
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
100 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
68788-8255-12026-01-29C16284748780-149896155-a5de-586f-e063-e6dba90add90These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
68788-8255-32026-01-29C16284748780-149896155-a5de-586f-e063-e6dba90add90These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
68788-8255-62026-01-29C16284748780-149896155-a5de-586f-e063-e6dba90add90These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
68788-8255-92026-01-29C16284748780-149896155-a5de-586f-e063-e6dba90add90These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8255-1Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
68788-8255-3Metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE303
68788-8255-6Metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE603
68788-8255-9Metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8255-1EA - Each68788-8255b5e4609d-9754-4715-9768-39de50ff955612022-10-06
68788-8255-3EA - Each68788-8255825ba1d5-570b-415a-afc6-fc1674b51fb212022-10-06
68788-8255-6EA - Each68788-825560e2db07-6116-4d9d-ab02-20890c6f5c1512022-10-06
68788-8255-9EA - Each68788-8255b70e57cc-2162-420d-b7fa-76e98f5785c912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8255METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC, 4 package rows20240718_d8185d8c-a0ed-4cb8-af53-438b8e00e02e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNd8185d8c-a0ed-4cb8-af53-438b8e00e02e3
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDd8185d8c-a0ed-4cb8-af53-438b8e00e02e3
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYd8185d8c-a0ed-4cb8-af53-438b8e00e02e3
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYd8185d8c-a0ed-4cb8-af53-438b8e00e02e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8255-168788825501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8255-1) 2022-09-020000-00-00NoNoCurrent
68788-8255-36878882550330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8255-3) 2022-09-020000-00-00NoNoCurrent
68788-8255-66878882550660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8255-6) 2022-09-020000-00-00NoNoCurrent
68788-8255-96878882550990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8255-9) 2022-09-020000-00-00NoNoCurrent