FDA.reportPublic FDA data

TOPROL XL

Product NDC
70842-110
11-digit product format
708420110
Labeler code
70842
Product ID
70842-110_a9037cc4-2d8d-45d5-9b89-2cd22c50d0a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Melinta Therapeutics, LLC
Application
NDA019962
Marketing category
NDA
Marketing start
2023-07-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOPROL XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438

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
70842-110-02TOPROL XL100 in 1 BOTTLETABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70842-110-02EA - Each70842-110aebe025d-a602-4125-bfaa-9876bf8e798712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70842-110TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [MELINTA THERAPEUTICS, LLC]5Current NDC, 1 package rows20241222_496ddfaa-7c9c-4888-b747-a210249b367a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866414Toprol XL 100 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866421Toprol XL 200 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866429Toprol XL 25 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
866438Toprol XL 50 MG 24HR Extended Release Oral TabletPSN496ddfaa-7c9c-4888-b747-a210249b367a7
86641424 HR metoprolol succinate 100 MG Extended Release Oral Tablet [Toprol]SBD496ddfaa-7c9c-4888-b747-a210249b367a7
86642124 HR metoprolol succinate 200 MG Extended Release Oral Tablet [Toprol]SBD496ddfaa-7c9c-4888-b747-a210249b367a7
86642924 HR metoprolol succinate 25 MG Extended Release Oral Tablet [Toprol]SBD496ddfaa-7c9c-4888-b747-a210249b367a7
86643824 HR metoprolol succinate 50 MG Extended Release Oral Tablet [Toprol]SBD496ddfaa-7c9c-4888-b747-a210249b367a7
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD496ddfaa-7c9c-4888-b747-a210249b367a7
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD496ddfaa-7c9c-4888-b747-a210249b367a7
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD496ddfaa-7c9c-4888-b747-a210249b367a7
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD496ddfaa-7c9c-4888-b747-a210249b367a7
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86641424 HR Toprol 100 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86642124 HR Toprol 200 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86642924 HR Toprol 25 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86643824 HR Toprol 50 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86641424 HR Toprol XL 100 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86642124 HR Toprol XL 200 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
86642924 HR Toprol XL 25 MG Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866414Toprol XL (metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866421Toprol XL (metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866429Toprol XL (metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866438Toprol XL (metoprolol succinate 50 MG (as metoprolol succinate 49.5 MG equivalent to 500 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866414Toprol XL 100 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866421Toprol XL 200 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866429Toprol XL 25 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7
866438Toprol XL 50 MG 24 HR Extended Release Oral TabletSY496ddfaa-7c9c-4888-b747-a210249b367a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70842-110-0270842011002100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70842-110-02) 2023-07-03NoNoHistorical