FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
50742-615
11-digit product format
507420615
Labeler code
50742
Product ID
50742-615_2613f8fb-4d2c-4e20-99b7-ccad1c745659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA204106
Marketing category
ANDA
Marketing start
2018-02-06
Substance
METOPROLOL SUCCINATE
Active strength
25 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 SUCCINATE25 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
50742-615-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
50742-615-05Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
50742-615-10Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009
50742-615-90Metoprolol Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE909
50742-615-99Metoprolol Succinate115384 in 1 DRUMTABLET, EXTENDED RELEASE1153849

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-615METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 5 package rows20230903_9dcd1fdf-a651-48d4-8033-e5749d5f5650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN9dcd1fdf-a651-48d4-8033-e5749d5f56509
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN9dcd1fdf-a651-48d4-8033-e5749d5f56509
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN9dcd1fdf-a651-48d4-8033-e5749d5f56509
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN9dcd1fdf-a651-48d4-8033-e5749d5f56509
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD9dcd1fdf-a651-48d4-8033-e5749d5f56509
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD9dcd1fdf-a651-48d4-8033-e5749d5f56509
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD9dcd1fdf-a651-48d4-8033-e5749d5f56509
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD9dcd1fdf-a651-48d4-8033-e5749d5f56509
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY9dcd1fdf-a651-48d4-8033-e5749d5f56509
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYbd0b68cc-3a7e-2223-e053-2995a90ac8f67
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN58d0fe08-f965-41cb-9592-fde060092b7e2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD58d0fe08-f965-41cb-9592-fde060092b7e2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY58d0fe08-f965-41cb-9592-fde060092b7e2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY58d0fe08-f965-41cb-9592-fde060092b7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-615-0150742061501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-615-01) 2018-02-060000-00-00NoNoCurrent
50742-615-0550742061505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-615-05) 2018-02-060000-00-00NoNoCurrent
50742-615-10507420615101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-615-10) 2018-02-060000-00-00NoNoCurrent
50742-615-905074206159090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-615-90) 2018-02-060000-00-00NoNoCurrent
50742-615-9950742061599115384 TABLET, EXTENDED RELEASE in 1 DRUM (50742-615-99) 2021-04-090000-00-00NoNoCurrent