FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
75834-291
11-digit product format
758340291
Labeler code
75834
Product ID
75834-291_0175a6b8-51dd-44d3-e063-6394a90a2f03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA203028
Marketing category
ANDA
Marketing start
2021-02-26
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
Rxcui866427, 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
75834-291-00Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002
75834-291-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
75834-291-05Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-291-00EA - Each75834-29118a36e2e-8c4a-4a6d-96cb-a18af4b17b9e12022-05-04
75834-291-01EA - Each75834-291a63b6d5f-1b9e-40d2-bd3c-af696c73d81c12022-05-04
75834-291-05EA - Each75834-291ae125e03-7414-4896-b784-8ced0e05c20d12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-291METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20230805_da7a5fcc-1794-e118-e053-2a95a90a25c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNda7a5fcc-1794-e118-e053-2a95a90a25c32
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNda7a5fcc-1794-e118-e053-2a95a90a25c32
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDda7a5fcc-1794-e118-e053-2a95a90a25c32
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDda7a5fcc-1794-e118-e053-2a95a90a25c32
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYda7a5fcc-1794-e118-e053-2a95a90a25c32
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYda7a5fcc-1794-e118-e053-2a95a90a25c32
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYda7a5fcc-1794-e118-e053-2a95a90a25c32
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYda7a5fcc-1794-e118-e053-2a95a90a25c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-291-00758340291001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-291-00) 2022-02-230000-00-00NoNoCurrent
75834-291-0175834029101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-291-01) 2022-02-230000-00-00NoNoCurrent
75834-291-0575834029105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-291-05) 2022-02-230000-00-00NoNoCurrent