FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
68788-8312
11-digit product format
687888312
Labeler code
68788
Product ID
68788-8312_1c06dffa-8633-45a9-9fba-28e7dafaa08b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207465
Marketing category
ANDA
Marketing start
2022-12-20
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
68788-8312-1METOPROLOL SUCCINATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
68788-8312-3METOPROLOL SUCCINATE30 in 1 BOTTLETABLET, EXTENDED RELEASE304
68788-8312-6METOPROLOL SUCCINATE60 in 1 BOTTLETABLET, EXTENDED RELEASE604
68788-8312-9METOPROLOL SUCCINATE90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8312-1EA - Each68788-83121d2e90a7-271f-4346-b791-6c19cb7b707112023-02-06
68788-8312-3EA - Each68788-8312e8eb51e7-6d39-4554-8b17-6a417dba2abe12023-02-06
68788-8312-6EA - Each68788-8312eab641ff-9ec9-477b-9dff-f7ef3bea3f0e12023-02-06
68788-8312-9EA - Each68788-831289c99c5a-60b7-4411-834f-46f1d0d2506b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8312METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 4 package rows20240718_7dfe56fe-68b6-4897-9238-0f530c92e27e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN7dfe56fe-68b6-4897-9238-0f530c92e27e4
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD7dfe56fe-68b6-4897-9238-0f530c92e27e4
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY7dfe56fe-68b6-4897-9238-0f530c92e27e4
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY7dfe56fe-68b6-4897-9238-0f530c92e27e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8312-168788831201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8312-1) 2022-12-200000-00-00NoNoCurrent
68788-8312-36878883120330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8312-3) 2022-12-200000-00-00NoNoCurrent
68788-8312-66878883120660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8312-6) 2022-12-200000-00-00NoNoCurrent
68788-8312-96878883120990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8312-9) 2022-12-200000-00-00NoNoCurrent