FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
50268-541
11-digit product format
502680541
Labeler code
50268
Product ID
50268-541_3d47f154-a33e-4290-e063-6294a90ad5c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA090617
Marketing category
ANDA
Marketing start
2018-07-25
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
50268-541-11Metoprolol succinate1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE18
50268-541-15Metoprolol succinate50 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-541-11EA - Each50268-5413968b911-3363-4387-bf23-c9720497da9012018-09-05
50268-541-15EA - Each50268-5414fc88248-a458-4e18-a09e-80c57388dde612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-541METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [AVPAK]7Current NDC, Legacy NDC, 2 package rows20250112_71b27b55-44aa-113d-e053-2995a90a1cf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-541-11502680541111 in 1 BLISTER PACKHistorical
50268-541-155026805411550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-541-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-541-11) 50 blister pack2018-07-250000-00-00NoNoCurrent