FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
50742-618
11-digit product format
507420618
Labeler code
50742
Product ID
50742-618_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
200 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 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
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
50742-618-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
50742-618-05Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
50742-618-10Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009
50742-618-90Metoprolol Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE909
50742-618-99Metoprolol Succinate16181 in 1 DRUMTABLET, EXTENDED RELEASE161819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-618-01EA - Each50742-618a24af270-6772-4b1c-a911-46572b27c71e12018-03-08
50742-618-05EA - Each50742-6187f80e529-ef1b-412c-bf51-a3b2238ddfb512018-03-08
50742-618-10EA - Each50742-61875265962-a745-4753-baeb-293a8c018c2b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-618METOPROLOL 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-618-0150742061801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-618-01) 2018-02-060000-00-00NoNoCurrent
50742-618-0550742061805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-618-05) 2018-02-060000-00-00NoNoCurrent
50742-618-10507420618101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-618-10) 2018-02-060000-00-00NoNoCurrent
50742-618-905074206189090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-618-90) 2018-02-060000-00-00NoNoCurrent
50742-618-995074206189916181 TABLET, EXTENDED RELEASE in 1 DRUM (50742-618-99) 2021-04-090000-00-00NoNoCurrent