FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
71205-350
11-digit product format
712050350
Labeler code
71205
Product ID
71205-350_8f22476a-dcca-4603-bf5e-5549a7c9fd0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204106
Marketing category
ANDA
Marketing start
2018-02-06
Substance
METOPROLOL SUCCINATE
Active strength
25 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 SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866427

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-350-30Metoprolol Succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-350-60Metoprolol Succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-350-90Metoprolol Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-350METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220421_58d0fe08-f965-41cb-9592-fde060092b7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN58d0fe08-f965-41cb-9592-fde060092b7e2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD58d0fe08-f965-41cb-9592-fde060092b7e2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY58d0fe08-f965-41cb-9592-fde060092b7e2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY58d0fe08-f965-41cb-9592-fde060092b7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-350-307120503503030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-350-30) 2019-11-010000-00-00NoNoCurrent
71205-350-607120503506060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-350-60) 2019-11-010000-00-00NoNoCurrent
71205-350-907120503509090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-350-90) 2019-11-010000-00-00NoNoCurrent