FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
70010-781
11-digit product format
700100781
Labeler code
70010
Product ID
70010-781_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
50 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 SUCCINATE50 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
70010-781-01Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
70010-781-05Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
70010-781-10Metoprolol Succinate1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-781-01EA - Each70010-7819b786dc8-0181-48ab-bf9b-7292595f4af812024-03-12
70010-781-05EA - Each70010-7818bcf7702-0637-40d0-9379-82f55e8b530e12024-03-12
70010-781-10EA - Each70010-78142e5e7f2-5596-4137-a92e-347714ea360d12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-781METOPROLOL 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
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN471bdbd7-7435-6786-e063-6294a90aa8a03
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD471bdbd7-7435-6786-e063-6294a90aa8a03
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY471bdbd7-7435-6786-e063-6294a90aa8a03
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY471bdbd7-7435-6786-e063-6294a90aa8a03
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
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN21e18c1c-fabb-44a4-a33a-b02a47967d731
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNa3aadb05-74e1-4c73-906c-be64f5242d361
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDa3aadb05-74e1-4c73-906c-be64f5242d361
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD21e18c1c-fabb-44a4-a33a-b02a47967d731
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY21e18c1c-fabb-44a4-a33a-b02a47967d731
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYa3aadb05-74e1-4c73-906c-be64f5242d361
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY21e18c1c-fabb-44a4-a33a-b02a47967d731
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYa3aadb05-74e1-4c73-906c-be64f5242d361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-781-0170010078101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-781-01) 2023-10-02NoNoCurrent
70010-781-0570010078105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-781-05) 2023-10-02NoNoCurrent
70010-781-10700100781101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-781-10) 2023-10-02NoNoCurrent