FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
72516-032
11-digit product format
725160032
Labeler code
72516
Product ID
72516-032_2b4bd7b3-d6df-e98e-e063-6394a90a7f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oryza Pharmaceuticals, Inc
Application
ANDA207206
Marketing category
ANDA
Marketing start
2022-04-27
Substance
METOPROLOL TARTRATE
Active strength
100 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 TARTRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866412, 866419, 866427, 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
72516-032-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
72516-032-10Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10003
72516-032-50Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-032-01EA - Each72516-03258c282c2-cc45-492a-8c1b-350b66b4869812022-08-04
72516-032-10EA - Each72516-032cdcf5f8f-907c-452d-a4d8-981e3e63b13012022-08-04
72516-032-50EA - Each72516-032462ac639-e8ca-41eb-acb9-8e886cdeede612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72516-032METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [ORYZA PHARMACEUTICALS, INC]3Current NDC, Legacy NDC, 3 package rows20250112_6cfe96df-bd75-432d-b2c2-e26143ca36dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN565bcddd-0720-484b-9316-d8fc0dc3ffab4
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD565bcddd-0720-484b-9316-d8fc0dc3ffab4
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY565bcddd-0720-484b-9316-d8fc0dc3ffab4
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY565bcddd-0720-484b-9316-d8fc0dc3ffab4
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN0ded3105-b962-4748-bf5b-fca7a45575623
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD0ded3105-b962-4748-bf5b-fca7a45575623
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY0ded3105-b962-4748-bf5b-fca7a45575623
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY0ded3105-b962-4748-bf5b-fca7a45575623
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY6cfe96df-bd75-432d-b2c2-e26143ca36dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72516-032-0172516003201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-032-01) 2022-04-270000-00-00NoNoCurrent
72516-032-10725160032101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-032-10) 2022-04-270000-00-00NoNoCurrent
72516-032-5072516003250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-032-50) 2022-04-270000-00-00NoNoCurrent