FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
75907-347
11-digit product format
759070347
Labeler code
75907
Product ID
75907-347_1bde60d8-4531-1810-842c-0457ecae21c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA090617
Marketing category
ANDA
Marketing start
2026-01-13
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
Rxcui866427, 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
75907-347-01Metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
75907-347-10Metoprolol 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
75907-347-01EA - Each75907-3474c4f62a8-56fd-49f1-a9b8-75cb04aa18dd12026-02-05
75907-347-10EA - Each75907-34763b9264d-0083-4edc-a49a-f48abab0f44512026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY24c87741-ee0a-738e-2c5a-5ce80ca2f48b2
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN51b630c7-6c03-7876-e063-6294a90acb301
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD51b630c7-6c03-7876-e063-6294a90acb301
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY51b630c7-6c03-7876-e063-6294a90acb301
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY51b630c7-6c03-7876-e063-6294a90acb301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75907-347-0175907034701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75907-347-01) 2026-01-13NoNoCurrent
75907-347-10759070347101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75907-347-10) 2026-01-13NoNoCurrent