FDA.reportPublic FDA data

metoprolol succinate

Product NDC
45963-678
11-digit product format
459630678
Labeler code
45963
Product ID
45963-678_e51ef0b9-fe4a-473c-92a0-6043fdb0b620
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204161
Marketing category
ANDA
Marketing start
2019-10-23
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, 866427, 866436

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-678-11metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-678-11EA - Each45963-67803a6acb1-7697-4754-b4d4-0c745901471412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-678METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]22Current NDC, Legacy NDC, 1 package rows20230821_b798601e-a369-4c8b-8235-08900e1b751d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNb798601e-a369-4c8b-8235-08900e1b751d26
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNb798601e-a369-4c8b-8235-08900e1b751d26
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNb798601e-a369-4c8b-8235-08900e1b751d26
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNb798601e-a369-4c8b-8235-08900e1b751d26
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDb798601e-a369-4c8b-8235-08900e1b751d26
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDb798601e-a369-4c8b-8235-08900e1b751d26
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDb798601e-a369-4c8b-8235-08900e1b751d26
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDb798601e-a369-4c8b-8235-08900e1b751d26
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYb798601e-a369-4c8b-8235-08900e1b751d26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-678-1145963067811100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-678-11) 2019-10-230000-00-00NoNoCurrent