FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
50090-7117
11-digit product format
500907117
Labeler code
50090
Product ID
50090-7117_350f51f1-500f-44f6-aea1-302354def04e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090617
Marketing category
ANDA
Marketing start
2023-04-10
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
50090-7117-0Metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
50090-7117-1Metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE902
50090-7117-3Metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7117-0EA - Each50090-71173bfd6aec-879f-46cc-95f7-0f19e4be754a12024-04-05
50090-7117-1EA - Each50090-7117ad4702d1-975a-431b-8872-1a62c38d5c9c12024-04-05
50090-7117-3EA - Each50090-71175944d937-986f-4a8b-9c3e-16cbefd25cf212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7117METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20240320_342846fb-d42f-4d96-a8b5-7bcf1dcaef2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN342846fb-d42f-4d96-a8b5-7bcf1dcaef2f2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD342846fb-d42f-4d96-a8b5-7bcf1dcaef2f2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY342846fb-d42f-4d96-a8b5-7bcf1dcaef2f2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY342846fb-d42f-4d96-a8b5-7bcf1dcaef2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7117-05009071170030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7117-0) 2024-03-18NoNoCurrent
50090-7117-15009071170190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7117-1) 2024-03-18NoNoCurrent
50090-7117-35009071170360 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7117-3) 2024-03-18NoNoCurrent