FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
31722-589
11-digit product format
317220589
Labeler code
31722
Product ID
31722-589_1376704a-04ff-0a4f-e063-6294a90ae9b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL SUCCINATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205541
Marketing category
ANDA
Marketing start
2020-11-06
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
Rxcui866412, 866419, 866427, 866436

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
31722-589-01METOPROLOL SUCCINATE100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
31722-589-05METOPROLOL SUCCINATE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005
31722-589-10METOPROLOL SUCCINATE1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10005
31722-589-30METOPROLOL SUCCINATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-589-01EA - Each31722-589e363ca4d-1531-4178-b15d-b007e79745dd12021-07-15
31722-589-05EA - Each31722-589df67a8f4-23d7-4343-998f-b5eeb1fd36d312021-07-15
31722-589-10EA - Each31722-58962cbc2dd-89b6-42d3-970b-1a306fc3321712021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-589METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240313_74a28333-53c1-493e-b6ad-2192fdc35391.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN74a28333-53c1-493e-b6ad-2192fdc353915
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN74a28333-53c1-493e-b6ad-2192fdc353915
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN74a28333-53c1-493e-b6ad-2192fdc353915
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN74a28333-53c1-493e-b6ad-2192fdc353915
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD74a28333-53c1-493e-b6ad-2192fdc353915
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD74a28333-53c1-493e-b6ad-2192fdc353915
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD74a28333-53c1-493e-b6ad-2192fdc353915
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD74a28333-53c1-493e-b6ad-2192fdc353915
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY74a28333-53c1-493e-b6ad-2192fdc353915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-589-0131722058901100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-589-01) 2020-11-060000-00-00NoNoCurrent
31722-589-0531722058905500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-589-05) 2021-04-230000-00-00NoNoCurrent
31722-589-10317220589101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-589-10) 2021-04-230000-00-00NoNoCurrent
31722-589-303172205893030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-589-30) 2020-11-060000-00-00NoNoCurrent