FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
71205-683
11-digit product format
712050683
Labeler code
71205
Product ID
71205-683_411ed6c7-c5e0-446c-9745-9095404dd0f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL SUCCINATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205541
Marketing category
ANDA
Marketing start
2020-11-06
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
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 SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
71205-683-30METOPROLOL SUCCINATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
71205-683-60METOPROLOL SUCCINATE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
71205-683-90METOPROLOL SUCCINATE90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-683METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20220816_411ed6c7-c5e0-446c-9745-9095404dd0f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN411ed6c7-c5e0-446c-9745-9095404dd0f61
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD411ed6c7-c5e0-446c-9745-9095404dd0f61
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY411ed6c7-c5e0-446c-9745-9095404dd0f61
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY411ed6c7-c5e0-446c-9745-9095404dd0f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-683-307120506833030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-683-30) 2022-08-110000-00-00NoNoCurrent
71205-683-607120506836060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-683-60) 2022-08-110000-00-00NoNoCurrent
71205-683-907120506839090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-683-90) 2022-08-110000-00-00NoNoCurrent