FDA.reportPublic FDA data

metoprolol succinate

Product NDC
63629-9413
11-digit product format
636299413
Labeler code
63629
Product ID
63629-9413_70b01456-0248-4418-b181-96651c537d9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
Substance
METOPROLOL SUCCINATE
Active strength
200 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 SUCCINATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866419

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
63629-9413-1metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE30102
63629-9413-2metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9413METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240510_6da0e3dc-1b11-4975-b35c-5a6ca13cf990.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN6da0e3dc-1b11-4975-b35c-5a6ca13cf990102
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD6da0e3dc-1b11-4975-b35c-5a6ca13cf990102
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY6da0e3dc-1b11-4975-b35c-5a6ca13cf990102
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY6da0e3dc-1b11-4975-b35c-5a6ca13cf990102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9413-16362994130130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9413-1) 2022-07-270000-00-00NoNoCurrent
63629-9413-26362994130290 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9413-2) 2022-07-270000-00-00NoNoCurrent