FDA.reportPublic FDA data

metoprolol succinate

Product NDC
71335-1878
11-digit product format
713351878
Labeler code
71335
Product ID
71335-1878_78863943-4e19-41b0-a98f-e6c59e63cabb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
metoprolol succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866436

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1878-1metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE30106
71335-1878-2metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE100106
71335-1878-3metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE90106
71335-1878-4metoprolol succinate120 in 1 BOTTLETABLET, EXTENDED RELEASE120106
71335-1878-5metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE60106
71335-1878-6metoprolol succinate180 in 1 BOTTLETABLET, EXTENDED RELEASE180106
71335-1878-7metoprolol succinate10 in 1 BOTTLETABLET, EXTENDED RELEASE10106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1878METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 7 package rows20240829_a1997b48-8d66-437a-a253-ca996331b0c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNa1997b48-8d66-437a-a253-ca996331b0c3106
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDa1997b48-8d66-437a-a253-ca996331b0c3106
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYa1997b48-8d66-437a-a253-ca996331b0c3106
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYa1997b48-8d66-437a-a253-ca996331b0c3106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1878-17133518780130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-1) 2021-08-170000-00-00NoNoCurrent
71335-1878-271335187802100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-2) 2021-09-130000-00-00NoNoCurrent
71335-1878-37133518780390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-3) 2021-06-140000-00-00NoNoCurrent
71335-1878-471335187804120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-4) 2022-09-190000-00-00NoNoCurrent
71335-1878-57133518780560 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-5) 2022-09-190000-00-00NoNoCurrent
71335-1878-671335187806180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-6) 2022-09-190000-00-00NoNoCurrent
71335-1878-77133518780710 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1878-7) 2022-09-190000-00-00NoNoCurrent