FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
70010-780
11-digit product format
700100780
Labeler code
70010
Product ID
70010-780_1c7ab139-2fb1-f011-e063-6394a90add6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA216916
Marketing category
ANDA
Marketing start
2023-10-02
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
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 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
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
70010-780-01Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
70010-780-05Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
70010-780-10Metoprolol Succinate1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-780METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]1Current NDC, 3 package rows20231002_ff180ca2-7490-a571-e053-6394a90a97b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN301ec2ea-84cb-ad89-e063-6294a90af49d6
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD301ec2ea-84cb-ad89-e063-6294a90af49d6
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY301ec2ea-84cb-ad89-e063-6294a90af49d6
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY301ec2ea-84cb-ad89-e063-6294a90af49d6
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN471f154c-197f-31df-e063-6394a90ae73e3
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD471f154c-197f-31df-e063-6394a90ae73e3
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY471f154c-197f-31df-e063-6394a90ae73e3
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY471f154c-197f-31df-e063-6394a90ae73e3
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNff180ca2-7490-a571-e053-6394a90a97b12
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNff180ca2-7490-a571-e053-6394a90a97b12
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNff180ca2-7490-a571-e053-6394a90a97b12
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNff180ca2-7490-a571-e053-6394a90a97b12
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDff180ca2-7490-a571-e053-6394a90a97b12
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDff180ca2-7490-a571-e053-6394a90a97b12
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDff180ca2-7490-a571-e053-6394a90a97b12
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDff180ca2-7490-a571-e053-6394a90a97b12
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYff180ca2-7490-a571-e053-6394a90a97b12
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN5223b690-0ccd-4ec4-b83b-22ce392713b21
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNf2d7c4da-9df0-44d4-9db3-e47e9cce92541
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNa34ba95a-a2d5-400e-8757-58c7bd20cad71
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN75f6c399-7a55-49a2-a8bb-dec534e375481
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN45723206-1a9d-5299-e063-6294a90ad9691
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN4a900d2c-12d1-6bfa-e063-6294a90af0091
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN4da96d34-ae8e-4c63-8ba0-bbeefdc205161
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN27e6ad55-0b5c-354b-e063-6394a90adeba1
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN27bb8bd5-b3ae-4eb3-b508-5684904408be1
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD5223b690-0ccd-4ec4-b83b-22ce392713b21
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD75f6c399-7a55-49a2-a8bb-dec534e375481
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD27e6ad55-0b5c-354b-e063-6394a90adeba1
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDa34ba95a-a2d5-400e-8757-58c7bd20cad71
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD45723206-1a9d-5299-e063-6294a90ad9691
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD27bb8bd5-b3ae-4eb3-b508-5684904408be1
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDf2d7c4da-9df0-44d4-9db3-e47e9cce92541
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD4a900d2c-12d1-6bfa-e063-6294a90af0091
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD4da96d34-ae8e-4c63-8ba0-bbeefdc205161
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY27e6ad55-0b5c-354b-e063-6394a90adeba1
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY27bb8bd5-b3ae-4eb3-b508-5684904408be1
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY45723206-1a9d-5299-e063-6294a90ad9691
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY4a900d2c-12d1-6bfa-e063-6294a90af0091
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY5223b690-0ccd-4ec4-b83b-22ce392713b21
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYf2d7c4da-9df0-44d4-9db3-e47e9cce92541
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYa34ba95a-a2d5-400e-8757-58c7bd20cad71
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY4da96d34-ae8e-4c63-8ba0-bbeefdc205161
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY75f6c399-7a55-49a2-a8bb-dec534e375481
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY4a900d2c-12d1-6bfa-e063-6294a90af0091
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYf2d7c4da-9df0-44d4-9db3-e47e9cce92541
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYa34ba95a-a2d5-400e-8757-58c7bd20cad71
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY45723206-1a9d-5299-e063-6294a90ad9691
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY27e6ad55-0b5c-354b-e063-6394a90adeba1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY4da96d34-ae8e-4c63-8ba0-bbeefdc205161
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY27bb8bd5-b3ae-4eb3-b508-5684904408be1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY75f6c399-7a55-49a2-a8bb-dec534e375481
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY5223b690-0ccd-4ec4-b83b-22ce392713b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-780-0170010078001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-780-01) 2023-10-02NoNoCurrent
70010-780-0570010078005500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-780-05) 2023-10-02NoNoCurrent
70010-780-10700100780101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-780-10) 2023-10-02NoNoCurrent