FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
62207-131
11-digit product format
622070131
Labeler code
62207
Product ID
62207-131_327de2c2-8091-50cc-e063-6394a90a14d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA216509
Marketing category
ANDA
Marketing start
2024-08-16
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
62207-131-49Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002
62207-131-54Metoprolol Succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-131METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [GRANULES INDIA LTD]1Current NDC, 2 package rows20240816_c5431c8a-d92c-489e-b63b-4b9cc8f32a1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62207-131-49622070131491000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-131-49) 2024-08-16NoNoCurrent
62207-131-546220701315430 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-131-54) 2024-08-16NoNoCurrent