FDA.reportPublic FDA data

metoprolol succinate

Product NDC
68382-564
11-digit product format
683820564
Labeler code
68382
Product ID
68382-564_2bad1abf-a566-4c58-8777-0f1a12b60690
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
Substance
METOPROLOL SUCCINATE
Active strength
25 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 SUCCINATE25 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
68382-564-01metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
68382-564-05metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
68382-564-10metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-564METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, Legacy NDC, 3 package rows20240222_bd77ec6e-c58c-440b-81d6-8a462b2fdc9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNadc8234b-192a-4ca4-a949-3eabc11af525106
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDadc8234b-192a-4ca4-a949-3eabc11af525106
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYadc8234b-192a-4ca4-a949-3eabc11af525106
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYadc8234b-192a-4ca4-a949-3eabc11af525106
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNcbc32a80-717b-4cf2-b76a-6d03a372041910
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDcbc32a80-717b-4cf2-b76a-6d03a372041910
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYcbc32a80-717b-4cf2-b76a-6d03a372041910
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYcbc32a80-717b-4cf2-b76a-6d03a372041910
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNea67ed64-47df-4728-8e62-c5d7316a71aa9
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDea67ed64-47df-4728-8e62-c5d7316a71aa9
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYea67ed64-47df-4728-8e62-c5d7316a71aa9
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYea67ed64-47df-4728-8e62-c5d7316a71aa9
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN7a5dd380-db2e-4db1-9172-d1837bbd439a5
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD7a5dd380-db2e-4db1-9172-d1837bbd439a5
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY7a5dd380-db2e-4db1-9172-d1837bbd439a5
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY7a5dd380-db2e-4db1-9172-d1837bbd439a5
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN471bca3e-3401-6814-e063-6394a90a9cb12
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD471bca3e-3401-6814-e063-6394a90a9cb12
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY471bca3e-3401-6814-e063-6394a90a9cb12
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY471bca3e-3401-6814-e063-6394a90a9cb12
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNf40d182a-598b-1e10-e053-2995a90a0d5b1
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN06fb25ae-fb1c-487f-a37e-0f57a4f529951
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD06fb25ae-fb1c-487f-a37e-0f57a4f529951
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDf40d182a-598b-1e10-e053-2995a90a0d5b1
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY06fb25ae-fb1c-487f-a37e-0f57a4f529951
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYf40d182a-598b-1e10-e053-2995a90a0d5b1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYf40d182a-598b-1e10-e053-2995a90a0d5b1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY06fb25ae-fb1c-487f-a37e-0f57a4f529951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-564-0168382056401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-564-01) 2018-06-070000-00-00NoNoCurrent
68382-564-0568382056405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-564-05) 2018-06-070000-00-00NoNoCurrent
68382-564-10683820564101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-564-10) 2018-06-070000-00-00NoNoCurrent