FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
61919-754
11-digit product format
619190754
Labeler code
61919
Product ID
61919-754_0e993203-3e65-5fbd-e063-6294a90a0636
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL SUCCINATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204106
Marketing category
ANDA
Marketing start
2019-05-02
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
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866427

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
61919-754-30METOPROLOL SUCCINATEER30 in 1 BOTTLETABLET, EXTENDED RELEASE305
61919-754-90METOPROLOL SUCCINATEER90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-754-90EA - Each61919-7549742d2a1-8686-4000-96d3-117cebb84b4e12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-754METOPROLOL SUCCINATE ER (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE METOPROLOL SUCCINATE ER TABLET, EXTENDED RELEASE [DIRECT_RX]5Current NDC, Legacy NDC, 2 package rows20240111_7ea78d2a-aa9f-38d4-e053-2991aa0a07fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY7ea78d2a-aa9f-38d4-e053-2991aa0a07fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-754-306191907543030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-754-30) 2019-05-020000-00-00NoNoCurrent
61919-754-906191907549090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-754-90) 2019-05-020000-00-00NoNoCurrent