FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
75834-292
11-digit product format
758340292
Labeler code
75834
Product ID
75834-292_01740be9-3731-2dd7-e063-6294a90a2b7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA203699
Marketing category
ANDA
Marketing start
2021-02-26
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

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
75834-292-00Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10003
75834-292-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
75834-292-05Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-292-00EA - Each75834-29204bfa3eb-1224-45aa-94ba-1a95bb55913312022-05-04
75834-292-01EA - Each75834-2921bb1343b-2980-4c42-9de9-7072827a8c4c12022-05-04
75834-292-05EA - Each75834-29244ab7b06-113e-4a2c-a519-41b1a9ed382712022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-292METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NIVAGEN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20230805_da7a72f9-2246-6934-e053-2995a90a6376.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNda7a72f9-2246-6934-e053-2995a90a63763
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNda7a72f9-2246-6934-e053-2995a90a63763
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDda7a72f9-2246-6934-e053-2995a90a63763
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDda7a72f9-2246-6934-e053-2995a90a63763
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYda7a72f9-2246-6934-e053-2995a90a63763
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYda7a72f9-2246-6934-e053-2995a90a63763
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYda7a72f9-2246-6934-e053-2995a90a63763
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYda7a72f9-2246-6934-e053-2995a90a63763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-292-00758340292001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-292-00) 2022-02-230000-00-00NoNoCurrent
75834-292-0175834029201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-292-01) 2022-02-230000-00-00NoNoCurrent
75834-292-0575834029205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-292-05) 2022-02-230000-00-00NoNoCurrent
75834-292-997583402929999000 TABLET, EXTENDED RELEASE in 1 DRUM (75834-292-99)01-DEC-20Current