FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
70010-782
11-digit product format
700100782
Labeler code
70010
Product ID
70010-782_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
100 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 SUCCINATE100 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
70010-782-01Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
70010-782-05Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
70010-782-10Metoprolol 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
70010-782-01EA - Each70010-782170be0e1-19e0-4ba3-901a-1d6525ece3bb12024-03-12
70010-782-05EA - Each70010-782974edf50-f4e2-4948-bb4f-b65c2c4968ca12024-03-12
70010-782-10EA - Each70010-7824293848e-9ee4-48e8-8091-cf80aa953e1812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-782METOPROLOL 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
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN47202157-3f32-275d-e063-6294a90a5c443
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD47202157-3f32-275d-e063-6294a90a5c443
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY47202157-3f32-275d-e063-6294a90a5c443
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY47202157-3f32-275d-e063-6294a90a5c443
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
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN57e12147-af06-421a-a2d6-99f0a0ce2b0e1
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNa46cbf09-20e3-4f0d-ab41-221f60fde0681
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN9bd9ff03-7c11-41c9-9054-126313d105061
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD57e12147-af06-421a-a2d6-99f0a0ce2b0e1
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDa46cbf09-20e3-4f0d-ab41-221f60fde0681
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD9bd9ff03-7c11-41c9-9054-126313d105061
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYa46cbf09-20e3-4f0d-ab41-221f60fde0681
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY9bd9ff03-7c11-41c9-9054-126313d105061
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY57e12147-af06-421a-a2d6-99f0a0ce2b0e1
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY57e12147-af06-421a-a2d6-99f0a0ce2b0e1
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYa46cbf09-20e3-4f0d-ab41-221f60fde0681
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY9bd9ff03-7c11-41c9-9054-126313d105061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-782-0170010078201100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-782-01) 2023-10-02NoNoCurrent
70010-782-0570010078205500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-782-05) 2023-10-02NoNoCurrent
70010-782-10700100782101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-782-10) 2023-10-02NoNoCurrent