FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
55648-736
11-digit product format
556480736
Labeler code
55648
Product ID
55648-736_47a324a2-9549-4f0e-ba7f-4259338b3f36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA090615
Marketing category
ANDA
Marketing start
2010-07-22
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
E
Listing certified through
2017-12-31
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
55648-736-012019-11-27C16284748780-19855d018-da7b-cd31-e053-dbdaa90ab51aThese 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, USP for Oral Use INITIAL U.S. APPROVAL: 1992
55648-736-022019-11-27C16284748780-19855d018-da7b-cd31-e053-dbdaa90ab51aThese 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, USP for Oral Use INITIAL U.S. APPROVAL: 1992
55648-736-032019-11-27C16284748780-19855d018-da7b-cd31-e053-dbdaa90ab51aThese 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, USP for Oral Use INITIAL U.S. APPROVAL: 1992
55648-736-052019-11-27C16284748780-19855d018-da7b-cd31-e053-dbdaa90ab51aThese 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, USP for Oral Use INITIAL U.S. APPROVAL: 1992
55648-736-082019-11-27C16284748780-19855d018-da7b-cd31-e053-dbdaa90ab51aThese 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, USP for Oral Use INITIAL U.S. APPROVAL: 1992
55648-736-092019-11-27C16284748780-19855d018-da7b-cd31-e053-dbdaa90ab51aThese 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, USP for Oral Use INITIAL U.S. APPROVAL: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-736-01Metoprolol Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
55648-736-02Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
55648-736-03Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005
55648-736-05Metoprolol Succinate10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE105
55648-736-05Metoprolol Succinate10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE105
55648-736-08Metoprolol Succinate3000 in 1 POUCHTABLET, FILM COATED, EXTENDED RE30005
55648-736-09Metoprolol Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
55648-736-09Metoprolol Succinate12 in 1 CARTONTABLET, FILM COATED, EXTENDED RE125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-736METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]5Legacy NDC, 8 package rows20130802_acad5e19-27c5-44fb-80f7-c05aa6859ecf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYacad5e19-27c5-44fb-80f7-c05aa6859ecf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-736-015564807360130 in 1 BOTTLEHistorical
55648-736-0255648073602100 in 1 BOTTLEHistorical
55648-736-0355648073603500 in 1 BOTTLEHistorical
55648-736-055564807360510 in 1 BLISTER PACKHistorical
55648-736-08556480736083000 in 1 POUCHHistorical
55648-736-095564807360930 in 1 BOTTLEHistorical