FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
72789-284
11-digit product format
727890284
Labeler code
72789
Product ID
72789-284_40bacd3a-ed47-93c6-e063-6294a90af100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
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
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
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
72789-284-30Metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3013
72789-284-90Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-284-30EA - Each72789-284d74c0a6e-154f-427e-8ad9-b06061e6507912023-02-06
72789-284-90EA - Each72789-284d9fb8f5d-d200-4d2c-b7d2-20b21f29a2db12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-284METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 2 package rows20240113_947f7982-2aea-40fb-a93b-c0a28f89da85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN947f7982-2aea-40fb-a93b-c0a28f89da8513
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD947f7982-2aea-40fb-a93b-c0a28f89da8513
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY947f7982-2aea-40fb-a93b-c0a28f89da8513
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY947f7982-2aea-40fb-a93b-c0a28f89da8513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-284-307278902843030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-284-30) 2022-10-250000-00-00NoNoCurrent
72789-284-907278902849090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-284-90) 2024-01-11NoNoCurrent