FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
51655-888
11-digit product format
516550888
Labeler code
51655
Product ID
51655-888_49740b5f-0ca7-2aa7-e063-6394a90a36e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA213854
Marketing category
ANDA
Marketing start
2023-04-18
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
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 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
51655-888-26Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
51655-888-52Metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-888METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240810_fa160cd3-4349-8e94-e053-6394a90a5887.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNfa160cd3-4349-8e94-e053-6394a90a58873
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDfa160cd3-4349-8e94-e053-6394a90a58873
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYfa160cd3-4349-8e94-e053-6394a90a58873
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYfa160cd3-4349-8e94-e053-6394a90a58873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-888-265165508882690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-888-26) 2023-04-19NoNoHistorical
51655-888-525165508885230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-888-52) 2023-04-18NoNoHistorical