FDA.reportPublic FDA data

metoprolol succinate

Product NDC
71205-368
11-digit product format
712050368
Labeler code
71205
Product ID
71205-368_d55d5cbf-532d-4387-a5a8-eb0b3d43e24e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204161
Marketing category
ANDA
Marketing start
2019-10-23
Substance
METOPROLOL SUCCINATE
Active strength
25 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 SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866427

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
71205-368-30metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71205-368-60metoprolol succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71205-368-90metoprolol succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-368-30EA - Each71205-368d7485153-0f4c-4c28-982b-94ad7a8f5b4212022-03-09
71205-368-90EA - Each71205-368b1dffea2-b4e2-4508-8b80-5d484ef09d0712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-368METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20230520_64c65611-d5c9-4802-9edd-32c7c67ce6f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN64c65611-d5c9-4802-9edd-32c7c67ce6f42
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD64c65611-d5c9-4802-9edd-32c7c67ce6f42
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY64c65611-d5c9-4802-9edd-32c7c67ce6f42
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY64c65611-d5c9-4802-9edd-32c7c67ce6f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-368-307120503683030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-368-30) 2019-12-030000-00-00NoNoCurrent
71205-368-607120503686060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-368-60) 2019-12-030000-00-00NoNoCurrent
71205-368-907120503689090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-368-90) 2019-12-030000-00-00NoNoCurrent