FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
70518-4090
11-digit product format
705184090
Labeler code
70518
Product ID
70518-4090_4caa848e-675a-3a63-e063-6294a90ad28a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207206
Marketing category
ANDA
Marketing start
2024-05-31
Substance
METOPROLOL TARTRATE
Active strength
25 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 TARTRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
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
70518-4090-0Metoprolol Succinate5 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE510
70518-4090-1Metoprolol Succinate30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3010
70518-4090-2Metoprolol Succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9010
70518-4090-3Metoprolol Succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3010
70518-4090-4Metoprolol Succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4090METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]4Current NDC, 5 package rows20250327_c1d1726f-75c6-4c07-b5ff-565c4c4ca904.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNc1d1726f-75c6-4c07-b5ff-565c4c4ca90410
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDc1d1726f-75c6-4c07-b5ff-565c4c4ca90410
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYc1d1726f-75c6-4c07-b5ff-565c4c4ca90410
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYc1d1726f-75c6-4c07-b5ff-565c4c4ca90410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4090-0705184090005 in 1 BOTTLE, PLASTICHistorical
70518-4090-17051840900130 in 1 BLISTER PACKHistorical
70518-4090-27051840900290 in 1 BOTTLE, PLASTICHistorical
70518-4090-37051840900330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4090-3) 2025-03-25NoNoHistorical
70518-4090-47051840900490 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4090-4) 2025-07-06NoNoHistorical