FDA.reportPublic FDA data

metoprolol succinate

Product NDC
68382-565
11-digit product format
683820565
Labeler code
68382
Product ID
68382-565_2bad1abf-a566-4c58-8777-0f1a12b60690
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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
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
68382-565-01metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
68382-565-05metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
68382-565-10metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-565-01EA - Each68382-5656dc78544-0509-411e-9cff-4df172dd1c2d12018-09-05
68382-565-10EA - Each68382-5656254c3c8-41e8-4fb2-9b8a-dd9580d81d2a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-565METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, Legacy NDC, 3 package rows20240222_bd77ec6e-c58c-440b-81d6-8a462b2fdc9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNa1997b48-8d66-437a-a253-ca996331b0c3106
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDa1997b48-8d66-437a-a253-ca996331b0c3106
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYa1997b48-8d66-437a-a253-ca996331b0c3106
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYa1997b48-8d66-437a-a253-ca996331b0c3106
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYbd77ec6e-c58c-440b-81d6-8a462b2fdc9c10
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNeea82ccb-876b-4fe8-9270-dcea509029a59
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDeea82ccb-876b-4fe8-9270-dcea509029a59
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYeea82ccb-876b-4fe8-9270-dcea509029a59
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYeea82ccb-876b-4fe8-9270-dcea509029a59
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYb8662d0c-f3c3-4331-aecb-6ba4e53785ef5
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN0b25ce23-6d78-bc88-e063-6294a90abb782
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNca8dbdc1-0137-8a89-e053-2995a90a66fd2
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD0b25ce23-6d78-bc88-e063-6294a90abb782
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDca8dbdc1-0137-8a89-e053-2995a90a66fd2
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYca8dbdc1-0137-8a89-e053-2995a90a66fd2
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY0b25ce23-6d78-bc88-e063-6294a90abb782
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYca8dbdc1-0137-8a89-e053-2995a90a66fd2
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY0b25ce23-6d78-bc88-e063-6294a90abb782
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNcdb69427-0489-3751-e053-2995a90a36671
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNe29d6ea1-1374-4572-ad7e-b0c2ea48ca041
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN15d5c223-af4e-e803-e063-6294a90af3d81
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDcdb69427-0489-3751-e053-2995a90a36671
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDe29d6ea1-1374-4572-ad7e-b0c2ea48ca041
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD15d5c223-af4e-e803-e063-6294a90af3d81
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYcdb69427-0489-3751-e053-2995a90a36671
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYe29d6ea1-1374-4572-ad7e-b0c2ea48ca041
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY15d5c223-af4e-e803-e063-6294a90af3d81
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY15d5c223-af4e-e803-e063-6294a90af3d81
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYcdb69427-0489-3751-e053-2995a90a36671
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYe29d6ea1-1374-4572-ad7e-b0c2ea48ca041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-565-0168382056501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-565-01) 2018-06-070000-00-00NoNoCurrent
68382-565-0568382056505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-565-05) 2018-06-070000-00-00NoNoCurrent
68382-565-10683820565101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-565-10) 2018-06-070000-00-00NoNoCurrent