FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
68001-469
11-digit product format
680010469
Labeler code
68001
Product ID
68001-469_026a8092-9638-f54d-e063-6294a90ab055
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207465
Marketing category
ANDA
Marketing start
2023-08-04
Substance
METOPROLOL SUCCINATE
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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866419, 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
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
68001-469-00METOPROLOL SUCCINATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
68001-469-08METOPROLOL SUCCINATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-469-00EA - Each68001-469c95f4997-f7f6-4b59-b024-15560f9c899c12021-04-08
68001-469-08EA - Each68001-469fe5948a0-a457-4c46-9dc1-f0b6a22b093512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-469METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20230809_6a4f2446-a9e4-479a-87bd-2d5539dcded9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN6a4f2446-a9e4-479a-87bd-2d5539dcded96
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN6a4f2446-a9e4-479a-87bd-2d5539dcded96
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN6a4f2446-a9e4-479a-87bd-2d5539dcded96
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD6a4f2446-a9e4-479a-87bd-2d5539dcded96
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD6a4f2446-a9e4-479a-87bd-2d5539dcded96
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD6a4f2446-a9e4-479a-87bd-2d5539dcded96
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY6a4f2446-a9e4-479a-87bd-2d5539dcded96
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY6a4f2446-a9e4-479a-87bd-2d5539dcded96
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY6a4f2446-a9e4-479a-87bd-2d5539dcded96
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY6a4f2446-a9e4-479a-87bd-2d5539dcded96
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY6a4f2446-a9e4-479a-87bd-2d5539dcded96
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY6a4f2446-a9e4-479a-87bd-2d5539dcded96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-469-0068001046900100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-469-00) 2023-08-040000-00-00NoNoCurrent
68001-469-08680010469081000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-469-08) 2023-08-070000-00-00NoNoCurrent