FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
72516-028
11-digit product format
725160028
Labeler code
72516
Product ID
72516-028_52af10c8-c2f0-56aa-e063-6394a90ad5ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oryza pharmaceuticals Inc.
Application
ANDA214110
Marketing category
ANDA
Marketing start
2025-07-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866419, 866436

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72516-028-01Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-028-01EA - Each72516-028588c2d81-8720-45c3-9e75-7af64ef18a2612025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN151079c5-6360-45ed-8118-885543d6a4ad4
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN151079c5-6360-45ed-8118-885543d6a4ad4
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN151079c5-6360-45ed-8118-885543d6a4ad4
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD151079c5-6360-45ed-8118-885543d6a4ad4
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD151079c5-6360-45ed-8118-885543d6a4ad4
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD151079c5-6360-45ed-8118-885543d6a4ad4
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72516-028-0172516002801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-028-01) 2025-07-21NoNoCurrent