FDA.reportPublic FDA data

metoprolol succinate

Product NDC
71335-1951
11-digit product format
713351951
Labeler code
71335
Product ID
71335-1951_2e24087e-4045-4b01-a72e-a1a37f8d3ee2
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
100 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 SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412

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
71335-1951-1metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE30105
71335-1951-2metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE90105
71335-1951-3metoprolol succinate120 in 1 BOTTLETABLET, EXTENDED RELEASE120105
71335-1951-4metoprolol succinate20 in 1 BOTTLETABLET, EXTENDED RELEASE20105
71335-1951-5metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE100105
71335-1951-6metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE60105
71335-1951-7metoprolol succinate10 in 1 BOTTLETABLET, EXTENDED RELEASE10105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1951METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 7 package rows20240504_d58b56cc-1a3d-4147-afc2-12e8236c3766.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNd58b56cc-1a3d-4147-afc2-12e8236c3766105
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDd58b56cc-1a3d-4147-afc2-12e8236c3766105
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYd58b56cc-1a3d-4147-afc2-12e8236c3766105
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYd58b56cc-1a3d-4147-afc2-12e8236c3766105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1951-17133519510130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-1) 2021-12-170000-00-00NoNoCurrent
71335-1951-27133519510290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-2) 2021-09-140000-00-00NoNoCurrent
71335-1951-371335195103120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-3) 2022-09-190000-00-00NoNoCurrent
71335-1951-47133519510420 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-4) 2022-09-190000-00-00NoNoCurrent
71335-1951-571335195105100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-5) 2022-09-190000-00-00NoNoCurrent
71335-1951-67133519510660 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-6) 2021-10-130000-00-00NoNoCurrent
71335-1951-77133519510710 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1951-7) 2022-09-190000-00-00NoNoCurrent