FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
69097-408
11-digit product format
690970408
Labeler code
69097
Product ID
69097-408_95bb3551-0e88-47cc-95e9-35c6dc731faf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA207465
Marketing category
ANDA
Marketing start
2019-03-25
Substance
METOPROLOL SUCCINATE
Active strength
100 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 SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866419, 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
69097-408-02METOPROLOL SUCCINATE30 in 1 BOTTLETABLET, EXTENDED RELEASE305
69097-408-07METOPROLOL SUCCINATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
69097-408-15METOPROLOL SUCCINATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-408-07EA - Each69097-408fe8d675d-9725-42de-a43b-1d2e1030070512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-408METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [CIPLA USA INC.]5Current NDC, Legacy NDC, 3 package rows20230413_3a4966a2-2728-4c99-999f-576b3e2df90c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN3a4966a2-2728-4c99-999f-576b3e2df90c5
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN3a4966a2-2728-4c99-999f-576b3e2df90c5
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN3a4966a2-2728-4c99-999f-576b3e2df90c5
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD3a4966a2-2728-4c99-999f-576b3e2df90c5
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD3a4966a2-2728-4c99-999f-576b3e2df90c5
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD3a4966a2-2728-4c99-999f-576b3e2df90c5
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY3a4966a2-2728-4c99-999f-576b3e2df90c5
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY3a4966a2-2728-4c99-999f-576b3e2df90c5
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY3a4966a2-2728-4c99-999f-576b3e2df90c5
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY3a4966a2-2728-4c99-999f-576b3e2df90c5
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY3a4966a2-2728-4c99-999f-576b3e2df90c5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY3a4966a2-2728-4c99-999f-576b3e2df90c5
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNa849d489-8f8c-18e6-e053-2995a90a37703
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDa849d489-8f8c-18e6-e053-2995a90a37703
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYa849d489-8f8c-18e6-e053-2995a90a37703
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYa849d489-8f8c-18e6-e053-2995a90a37703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-408-026909704080230 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-408-02) 2019-03-250000-00-00NoNoCurrent
69097-408-0769097040807100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-408-07) 2019-03-250000-00-00NoNoCurrent
69097-408-15690970408151000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-408-15) 2019-03-250000-00-00NoNoCurrent