FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
42806-725
11-digit product format
428060725
Labeler code
42806
Product ID
42806-725_2c74614f-0615-6839-e063-6294a90acc19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA213854
Marketing category
ANDA
Marketing start
2025-02-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-725-01Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
42806-725-05Metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
42806-725-10Metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-725-01EA - Each42806-72568f23aca-e1bc-46dc-b3a4-b7a7259d7aa712025-05-14
42806-725-05EA - Each42806-725f3af70f6-1fba-4bdf-af25-92a03836c8e712025-05-14
42806-725-10EA - Each42806-7250c673fac-dc8f-48c3-a1dc-e547b763b83d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-725METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [EPIC PHARMA, LLC]2Current NDC, 3 package rows20250201_2c70177a-615b-4ed7-a58f-a298212e8fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN2c70177a-615b-4ed7-a58f-a298212e8fae2
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN2c70177a-615b-4ed7-a58f-a298212e8fae2
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN2c70177a-615b-4ed7-a58f-a298212e8fae2
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN2c70177a-615b-4ed7-a58f-a298212e8fae2
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD2c70177a-615b-4ed7-a58f-a298212e8fae2
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD2c70177a-615b-4ed7-a58f-a298212e8fae2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD2c70177a-615b-4ed7-a58f-a298212e8fae2
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD2c70177a-615b-4ed7-a58f-a298212e8fae2
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY2c70177a-615b-4ed7-a58f-a298212e8fae2
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN48ec9246-f887-2ed4-e063-6394a90ac9521
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD48ec9246-f887-2ed4-e063-6394a90ac9521
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY48ec9246-f887-2ed4-e063-6394a90ac9521
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY48ec9246-f887-2ed4-e063-6394a90ac9521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-725-0142806072501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-725-01) 2025-02-01NoNoCurrent
42806-725-0542806072505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-725-05) 2025-02-01NoNoCurrent
42806-725-10428060725101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-725-10) 2025-02-01NoNoCurrent