FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
71205-336
11-digit product format
712050336
Labeler code
71205
Product ID
71205-336_423bd774-b131-4d13-b7b7-afc98d6ceeb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204106
Marketing category
ANDA
Marketing start
2018-02-06
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

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-336-30Metoprolol Succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-336-60Metoprolol Succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-336-90Metoprolol Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-336-30EA - Each71205-3365a0a9082-daf7-49b0-b1a7-28a0a49b01db12020-03-10
71205-336-90EA - Each71205-336cb25f6e9-b7ed-460a-ba31-0d58925c27dd12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-336METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20200111_25d7926c-061f-4eb0-8d30-6397efeca16d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN25d7926c-061f-4eb0-8d30-6397efeca16d2
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD25d7926c-061f-4eb0-8d30-6397efeca16d2
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY25d7926c-061f-4eb0-8d30-6397efeca16d2
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY25d7926c-061f-4eb0-8d30-6397efeca16d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-336-307120503363030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-336-30) 2019-10-010000-00-00NoNoCurrent
71205-336-607120503366060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-336-60) 2019-10-010000-00-00NoNoCurrent
71205-336-907120503369090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-336-90) 2019-10-010000-00-00NoNoCurrent