FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
68788-4022
11-digit product format
687884022
Labeler code
68788
Product ID
68788-4022_27bb8bd5-b3ae-4eb3-b508-5684904408be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216916
Marketing category
ANDA
Marketing start
2025-09-05
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
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 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
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
68788-4022-3Metoprolol Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
68788-4022-6Metoprolol Succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
68788-4022-9Metoprolol Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4022-3EA - Each68788-402262eedb88-725e-4dda-9700-8746fa397c6112025-11-13
68788-4022-6EA - Each68788-4022290757e2-2743-499a-90fc-756c5ee6e02d12025-11-13
68788-4022-9EA - Each68788-4022fb2f83d4-34d3-43be-9139-d0a079bd808a12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN27bb8bd5-b3ae-4eb3-b508-5684904408be1
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD27bb8bd5-b3ae-4eb3-b508-5684904408be1
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY27bb8bd5-b3ae-4eb3-b508-5684904408be1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY27bb8bd5-b3ae-4eb3-b508-5684904408be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4022-36878840220330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-4022-3) 2025-09-05NoNoCurrent
68788-4022-66878840220660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-4022-6) 2025-09-05NoNoCurrent
68788-4022-96878840220990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-4022-9) 2025-09-05NoNoCurrent