FDA.reportPublic FDA data

Metoprolol Succinate ER

Product NDC
72189-547
11-digit product format
721890547
Labeler code
72189
Product ID
72189-547_15d5c223-af4f-e803-e063-6294a90af3d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203894
Marketing category
ANDA
Marketing start
2024-04-11
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 ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866436

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
72189-547-90Metoprolol Succinate ER90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-547-90EA - Each72189-547739d1034-c279-48d4-922e-c4c674288c6212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-547METOPROLOL SUCCINATE ER TABLET, EXTENDED RELEASE [DIRECT_RX]1Current NDC, 1 package rows20240418_15d5c223-af4e-e803-e063-6294a90af3d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN15d5c223-af4e-e803-e063-6294a90af3d81
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD15d5c223-af4e-e803-e063-6294a90af3d81
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY15d5c223-af4e-e803-e063-6294a90af3d81
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY15d5c223-af4e-e803-e063-6294a90af3d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-547-907218905479090 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-547-90) 2024-04-11NoNoCurrent