FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
71765-008
11-digit product format
717650008
Labeler code
71765
Product ID
71765-008_4df90eca-70e4-5c7c-e063-6294a90adc41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zhejiang Jutai Pharamceutical Co., Ltd
Application
ANDA214110
Marketing category
ANDA
Marketing start
2020-11-16
Substance
METOPROLOL SUCCINATE
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866419, 866436

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
71765-008-01Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
71765-008-02Metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN4df90eca-70e3-5c7c-e063-6294a90adc414
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN4df90eca-70e3-5c7c-e063-6294a90adc414
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN4df90eca-70e3-5c7c-e063-6294a90adc414
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD4df90eca-70e3-5c7c-e063-6294a90adc414
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD4df90eca-70e3-5c7c-e063-6294a90adc414
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD4df90eca-70e3-5c7c-e063-6294a90adc414
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY4df90eca-70e3-5c7c-e063-6294a90adc414
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY4df90eca-70e3-5c7c-e063-6294a90adc414
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY4df90eca-70e3-5c7c-e063-6294a90adc414
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY4df90eca-70e3-5c7c-e063-6294a90adc414
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY4df90eca-70e3-5c7c-e063-6294a90adc414
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY4df90eca-70e3-5c7c-e063-6294a90adc414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71765-008-0171765000801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71765-008-01) 2020-11-16NoNoHistorical
71765-008-02717650008021000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71765-008-02) 2020-11-16NoNoHistorical