FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
71610-484
11-digit product format
716100484
Labeler code
71610
Product ID
71610-484_497ad965-223e-2fa8-e063-6394a90a68cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA019962
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-01
Substance
METOPROLOL SUCCINATE
Active strength
100 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 SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866427

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
71610-484-45METOPROLOL SUCCINATE45 in 1 BOTTLETABLET, EXTENDED RELEASE452
71610-484-60METOPROLOL SUCCINATE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-484-45EA - Each71610-4849a9c3f8e-2f15-4eb3-bade-56564f04147412021-02-05
71610-484-60EA - Each71610-48415961ba2-a78c-47e9-b855-5d0c22584ac012021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-484METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20201212_1b926135-a67f-4386-a2ba-de5d9fd5a7c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN1b926135-a67f-4386-a2ba-de5d9fd5a7c52
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-484-457161004844545 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-484-45) 2020-11-100000-00-00NoNoCurrent
71610-484-607161004846090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-484-60) 2020-11-100000-00-00NoNoCurrent