FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
50090-6488
11-digit product format
500906488
Labeler code
50090
Product ID
50090-6488_f6eb4df4-393d-4ecb-ba1a-6b4e5fa493bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207206
Marketing category
ANDA
Marketing start
2022-04-27
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
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 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
50090-6488-0Metoprolol Succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE301
50090-6488-1Metoprolol Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE901
50090-6488-3Metoprolol Succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6488-0EA - Each50090-6488e839ad69-01e6-4893-aa06-27fe2cfe53c812023-06-06
50090-6488-1EA - Each50090-64887a8c793a-e01f-4eb8-a8d2-4e4b18cec9f112023-06-06
50090-6488-3EA - Each50090-64889c283226-0223-4a8b-945c-d05714a6cb7c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6488METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230524_5ee51a50-0187-4156-84fa-95e68f5c353b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN5ee51a50-0187-4156-84fa-95e68f5c353b1
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD5ee51a50-0187-4156-84fa-95e68f5c353b1
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY5ee51a50-0187-4156-84fa-95e68f5c353b1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY5ee51a50-0187-4156-84fa-95e68f5c353b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6488-05009064880030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6488-0) 2023-05-17NoNoCurrent
50090-6488-15009064880190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6488-1) 2023-05-17NoNoCurrent
50090-6488-35009064880360 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6488-3) 2023-05-17NoNoCurrent