FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
43063-624
11-digit product format
430630624
Labeler code
43063
Product ID
43063-624_4139c656-59e1-3145-e063-6294a90a67e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
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
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
43063-624-30Metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3020
43063-624-60Metoprolol succinate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE6020
43063-624-90Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-624-30EA - Each43063-624baef8928-6511-4c69-ae13-bdec2879044f12016-04-04
43063-624-60EA - Each43063-624b1faf1b3-97bb-4eeb-8a87-db560254299b12023-02-06
43063-624-90EA - Each43063-624121590fc-674d-44e6-93d7-a40f53dc31fc12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-624METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 3 package rows20240906_4eea76dd-af6d-419a-90e4-ba9eff3b2c73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN4eea76dd-af6d-419a-90e4-ba9eff3b2c7320
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD4eea76dd-af6d-419a-90e4-ba9eff3b2c7320
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY4eea76dd-af6d-419a-90e4-ba9eff3b2c7320
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY4eea76dd-af6d-419a-90e4-ba9eff3b2c7320

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-624-304306306243030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-30) 2015-10-260000-00-00NoNoCurrent
43063-624-604306306246060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-60) 2023-01-110000-00-00NoNoCurrent
43063-624-904306306249090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-90) 2020-07-290000-00-00NoNoCurrent