FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
72789-497
11-digit product format
727890497
Labeler code
72789
Product ID
72789-497_30a04a9e-783b-9d04-e063-6394a90ac631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA207206
Marketing category
ANDA
Marketing start
2022-04-27
Substance
METOPROLOL TARTRATE
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 TARTRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866436

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
72789-497-90Metoprolol Succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-497METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20250321_4d8cdd8b-3896-4cd0-9570-a6f4e1d340d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY4d8cdd8b-3896-4cd0-9570-a6f4e1d340d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-497-907278904979090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-497-90) 2025-03-18NoNoCurrent