FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
50090-7069
11-digit product format
500907069
Labeler code
50090
Product ID
50090-7069_6b3de42b-6ac9-47cb-a809-be0d55af6e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078889
Marketing category
ANDA
Marketing start
2023-04-10
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
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
50090-7069-0Metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE304
50090-7069-1Metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7069-0EA - Each50090-7069d88f4fb7-ba97-4003-bd43-d7a22fd2590912024-03-12
50090-7069-1EA - Each50090-706900b5f5ed-d60d-4053-8395-9969892a06aa12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7069METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, 2 package rows20240619_aa1c7d31-78be-465f-9564-03685a58add8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNaa1c7d31-78be-465f-9564-03685a58add84
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDaa1c7d31-78be-465f-9564-03685a58add84
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYaa1c7d31-78be-465f-9564-03685a58add84
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYaa1c7d31-78be-465f-9564-03685a58add84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7069-05009070690030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7069-0) 2024-01-19NoNoHistorical
50090-7069-15009070690190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7069-1) 2024-01-19NoNoHistorical