FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
68001-501
11-digit product format
680010501
Labeler code
68001
Product ID
68001-501_47e38e34-d590-f7ab-e063-6394a90aa6a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA211143
Marketing category
ANDA
Marketing start
2021-05-14
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
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 SUCCINATE50 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
68001-501-00Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009
68001-501-03Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5009
68001-501-08Metoprolol Succinate1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-501-00EA - Each68001-501fbed2010-d809-4b01-b5fd-1a564b13382312021-08-05
68001-501-03EA - Each68001-50157a61d4a-92cd-4aaf-96f4-42dbab656ecd12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-501METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 3 package rows20230830_6588d77c-090f-4722-9c91-437887d4624a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN6588d77c-090f-4722-9c91-437887d4624a9
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN6588d77c-090f-4722-9c91-437887d4624a9
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN6588d77c-090f-4722-9c91-437887d4624a9
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN6588d77c-090f-4722-9c91-437887d4624a9
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD6588d77c-090f-4722-9c91-437887d4624a9
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD6588d77c-090f-4722-9c91-437887d4624a9
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD6588d77c-090f-4722-9c91-437887d4624a9
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD6588d77c-090f-4722-9c91-437887d4624a9
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY6588d77c-090f-4722-9c91-437887d4624a9
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN26a52cf5-29c7-7515-e063-6394a90a90991
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD26a52cf5-29c7-7515-e063-6394a90a90991
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY26a52cf5-29c7-7515-e063-6394a90a90991
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY26a52cf5-29c7-7515-e063-6394a90a90991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-501-0068001050100100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-501-00) 2021-05-140000-00-00NoNoCurrent
68001-501-0368001050103500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-501-03) 2021-05-140000-00-00NoNoCurrent
68001-501-08680010501081000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-501-08) 2021-05-140000-00-00NoNoCurrent