FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
72516-031
11-digit product format
725160031
Labeler code
72516
Product ID
72516-031_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
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 TARTRATE50 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
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
72516-031-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
72516-031-10Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10003
72516-031-50Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-031-01EA - Each72516-031f402af4f-e669-459f-aa33-69a0ad9b219212022-08-04
72516-031-10EA - Each72516-0315089478f-ab2d-4f99-8ab2-06d473c036a512022-08-04
72516-031-50EA - Each72516-031cf1bc642-4fd8-465f-a929-29929b546e7012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72516-031METOPROLOL 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 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 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
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
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
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN502653e6-1971-4abf-9b21-ba0a9957672b1
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN4b1cfb2f-2345-af53-e063-6294a90a4ff01
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNe91e8ee2-4a54-4932-9d8b-5831121377a41
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD502653e6-1971-4abf-9b21-ba0a9957672b1
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDe91e8ee2-4a54-4932-9d8b-5831121377a41
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD4b1cfb2f-2345-af53-e063-6294a90a4ff01
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYe91e8ee2-4a54-4932-9d8b-5831121377a41
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY502653e6-1971-4abf-9b21-ba0a9957672b1
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY4b1cfb2f-2345-af53-e063-6294a90a4ff01
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY502653e6-1971-4abf-9b21-ba0a9957672b1
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYe91e8ee2-4a54-4932-9d8b-5831121377a41
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY4b1cfb2f-2345-af53-e063-6294a90a4ff01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72516-031-0172516003101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-01) 2022-04-270000-00-00NoNoCurrent
72516-031-10725160031101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-10) 2022-04-270000-00-00NoNoCurrent
72516-031-5072516003150500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-50) 2022-04-270000-00-00NoNoCurrent