FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
63304-009
11-digit product format
633040009
Labeler code
63304
Product ID
63304-009_32a6b020-3673-469f-8757-741297fb458b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries Inc.
Application
NDA210428
Marketing category
NDA
Marketing start
2018-02-07
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
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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui1999031, 1999033, 1999035, 1999037

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
63304-009-30Metoprolol Succinate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-009METOPROLOL SUCCINATE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES INC.]9Current NDC, Legacy NDC, 1 package rows20180208_90aa06a3-100f-4466-b950-506303707b01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999031metoprolol succinate 100 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
1999033metoprolol succinate 200 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
1999035metoprolol succinate 25 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
1999037metoprolol succinate 50 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
199903124 HR metoprolol succinate 100 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
199903324 HR metoprolol succinate 200 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
199903524 HR metoprolol succinate 25 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
199903724 HR metoprolol succinate 50 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
1999031metoprolol succinate 100 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019
1999033metoprolol succinate 200 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019
1999035metoprolol succinate 25 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019
1999037metoprolol succinate 50 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-009-306330400093030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-009-30) 2018-02-070000-00-00NoNoCurrent