FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
75907-345
11-digit product format
759070345
Labeler code
75907
Product ID
75907-345_9b4078bf-b309-c50b-d195-b4722dfb0945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA078889
Marketing category
ANDA
Marketing start
2026-01-13
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
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 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
75907-345-01Metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
75907-345-10Metoprolol succinate1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-345-01EA - Each75907-345997ea6df-9292-4638-8004-bdf3340ff23512026-02-05
75907-345-10EA - Each75907-3457d06dfc4-7ee0-4ea4-9df2-3fa7ab94aef312026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN5b7095c8-f8b7-adc7-9052-92325da33a022
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN5b7095c8-f8b7-adc7-9052-92325da33a022
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD5b7095c8-f8b7-adc7-9052-92325da33a022
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD5b7095c8-f8b7-adc7-9052-92325da33a022
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY5b7095c8-f8b7-adc7-9052-92325da33a022
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY5b7095c8-f8b7-adc7-9052-92325da33a022
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY5b7095c8-f8b7-adc7-9052-92325da33a022
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY5b7095c8-f8b7-adc7-9052-92325da33a022
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN52bdc5cc-973f-4af6-e063-6294a90aba221
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD52bdc5cc-973f-4af6-e063-6294a90aba221
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY52bdc5cc-973f-4af6-e063-6294a90aba221
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY52bdc5cc-973f-4af6-e063-6294a90aba221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75907-345-0175907034501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75907-345-01) 2026-01-13NoNoHistorical
75907-345-10759070345101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75907-345-10) 2026-01-13NoNoHistorical