FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
72603-145
11-digit product format
726030145
Labeler code
72603
Product ID
72603-145_ab3584df-a821-6eb3-7548-0306ce2d1a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA078889
Marketing category
ANDA
Marketing start
2023-04-10
Substance
METOPROLOL SUCCINATE
Active strength
200 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 SUCCINATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866419

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
72603-145-01Metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
72603-145-02Metoprolol succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-145-01EA - Each72603-145fc47ae32-f701-4789-b572-9799ff0638ed12023-07-06
72603-145-02EA - Each72603-1451f692e6c-3a35-4d9c-906d-3625a2d437d712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-145METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]4Current NDC, 2 package rows20230922_d887be8a-e6c2-5129-edbd-d7b2c0283dca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNd887be8a-e6c2-5129-edbd-d7b2c0283dca5
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNd887be8a-e6c2-5129-edbd-d7b2c0283dca5
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDd887be8a-e6c2-5129-edbd-d7b2c0283dca5
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDd887be8a-e6c2-5129-edbd-d7b2c0283dca5
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYd887be8a-e6c2-5129-edbd-d7b2c0283dca5
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYd887be8a-e6c2-5129-edbd-d7b2c0283dca5
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYd887be8a-e6c2-5129-edbd-d7b2c0283dca5
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYd887be8a-e6c2-5129-edbd-d7b2c0283dca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-145-0172603014501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-145-01) 2023-04-10NoNoCurrent
72603-145-0272603014502500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-145-02) 2023-04-10NoNoCurrent