FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
55154-4698
11-digit product format
551544698
Labeler code
55154
Product ID
55154-4698_fcdb8e98-61f7-46c5-a794-66ba6a032341
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090617
Marketing category
ANDA
Marketing start
2018-09-25
Substance
METOPROLOL SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866427

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
55154-4698-0Metoprolol Succinate1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE16
55154-4698-0Metoprolol Succinate10 in 1 BAGTABLET, FILM COATED, EXTENDED RE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4698METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20250302_028049cd-d233-49f9-87fa-ec91e433a49f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN028049cd-d233-49f9-87fa-ec91e433a49f6
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD028049cd-d233-49f9-87fa-ec91e433a49f6
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY028049cd-d233-49f9-87fa-ec91e433a49f6
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY028049cd-d233-49f9-87fa-ec91e433a49f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4698-05515446980010 BLISTER PACK in 1 BAG (55154-4698-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2018-09-250000-00-00NoNoCurrent