FDA.reportPublic FDA data

metoprolol succinate

Product NDC
68788-7997
11-digit product format
687887997
Labeler code
68788
Product ID
68788-7997_25365bf6-6b2b-4ffe-8012-7b346c2b5fdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203894
Marketing category
ANDA
Marketing start
2021-08-10
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
68788-7997-1metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
68788-7997-3metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
68788-7997-6metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE605
68788-7997-9metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7997-1EA - Each68788-799746b9eae4-39bc-4e06-9728-e989ce1d929312021-09-07
68788-7997-3EA - Each68788-7997c3eaf319-31b9-4801-b66b-ca93f93be20412021-09-07
68788-7997-6EA - Each68788-7997f73ab35a-a850-4bab-a002-e93ada6c3a9412021-09-07
68788-7997-9EA - Each68788-7997c89ae939-ae6e-4d69-b380-a06396ca580512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7997METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240718_b8662d0c-f3c3-4331-aecb-6ba4e53785ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYb8662d0c-f3c3-4331-aecb-6ba4e53785ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7997-168788799701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7997-1) 2021-08-100000-00-00NoNoCurrent
68788-7997-36878879970330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7997-3) 2021-08-100000-00-00NoNoCurrent
68788-7997-66878879970660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7997-6) 2021-08-100000-00-00NoNoCurrent
68788-7997-96878879970990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7997-9) 2021-08-100000-00-00NoNoCurrent