FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
63629-9170
11-digit product format
636299170
Labeler code
63629
Product ID
63629-9170_e0feb85e-57e7-40ee-b1b7-e04325edfd8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211143
Marketing category
ANDA
Marketing start
2020-11-27
Substance
METOPROLOL SUCCINATE
Active strength
50 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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866436

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
63629-9170-1Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE500105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9170-1EA - Each63629-9170ef61f6af-5995-42ea-b88f-f6bfd228f1bf12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9170METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20250331_123f2051-4bff-4621-aaba-65f54f4e7784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN123f2051-4bff-4621-aaba-65f54f4e7784105
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD123f2051-4bff-4621-aaba-65f54f4e7784105
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY123f2051-4bff-4621-aaba-65f54f4e7784105
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY123f2051-4bff-4621-aaba-65f54f4e7784105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9170-163629917001500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9170-1) 2020-11-270000-00-00NoNoCurrent