FDA.reportPublic FDA data

metoprolol succinate

Product NDC
70771-1341
11-digit product format
707711341
Labeler code
70771
Product ID
70771-1341_925a10b7-f9bd-42a0-80db-d440a2eba4d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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, 866427, 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70771-1341-0metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE100010
70771-1341-1metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
70771-1341-5metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1341METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 3 package rows20240222_1098f26d-8319-4dba-ad66-3df22db2b399.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN1098f26d-8319-4dba-ad66-3df22db2b39910
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN1098f26d-8319-4dba-ad66-3df22db2b39910
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN1098f26d-8319-4dba-ad66-3df22db2b39910
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN1098f26d-8319-4dba-ad66-3df22db2b39910
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD1098f26d-8319-4dba-ad66-3df22db2b39910
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD1098f26d-8319-4dba-ad66-3df22db2b39910
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD1098f26d-8319-4dba-ad66-3df22db2b39910
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD1098f26d-8319-4dba-ad66-3df22db2b39910
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY1098f26d-8319-4dba-ad66-3df22db2b39910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1341-0707711341001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1341-0) 2018-06-070000-00-00NoNoCurrent
70771-1341-170771134101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1341-1) 2018-06-070000-00-00NoNoCurrent
70771-1341-570771134105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1341-5) 2018-06-070000-00-00NoNoCurrent