FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
67877-593
11-digit product format
678770593
Labeler code
67877
Product ID
67877-593_7b6e362b-e8bc-45ee-b369-7109fb60adeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211143
Marketing category
ANDA
Marketing start
2020-11-27
Substance
METOPROLOL SUCCINATE
Active strength
200 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 SUCCINATE200 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
67877-593-01Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10013
67877-593-05Metoprolol Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50013
67877-593-10Metoprolol Succinate1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100013
67877-593-30Metoprolol Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3013
67877-593-60Metoprolol Succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-593-01EA - Each67877-593c42ba98c-5dc7-4718-9666-1e8b175a0c2112021-04-08
67877-593-05EA - Each67877-593243e3bab-a91d-4f4f-8a81-d24ba7df404712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-593METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]12Current NDC, Legacy NDC, 5 package rows20250216_58441cd3-6043-4bb8-adab-1b32a203bfb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN01908d20-0e16-4410-bd27-1b6df162ede4104
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN26d22b60-4414-40e3-9157-5e67340a0106104
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNafa6c1f5-0c8e-496f-930a-1ade1f69646b104
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD01908d20-0e16-4410-bd27-1b6df162ede4104
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD26d22b60-4414-40e3-9157-5e67340a0106104
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDafa6c1f5-0c8e-496f-930a-1ade1f69646b104
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY01908d20-0e16-4410-bd27-1b6df162ede4104
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY26d22b60-4414-40e3-9157-5e67340a0106104
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYafa6c1f5-0c8e-496f-930a-1ade1f69646b104
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY01908d20-0e16-4410-bd27-1b6df162ede4104
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYafa6c1f5-0c8e-496f-930a-1ade1f69646b104
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY26d22b60-4414-40e3-9157-5e67340a0106104
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN58441cd3-6043-4bb8-adab-1b32a203bfb213
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN58441cd3-6043-4bb8-adab-1b32a203bfb213
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN58441cd3-6043-4bb8-adab-1b32a203bfb213
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN58441cd3-6043-4bb8-adab-1b32a203bfb213
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD58441cd3-6043-4bb8-adab-1b32a203bfb213
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD58441cd3-6043-4bb8-adab-1b32a203bfb213
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD58441cd3-6043-4bb8-adab-1b32a203bfb213
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD58441cd3-6043-4bb8-adab-1b32a203bfb213
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY58441cd3-6043-4bb8-adab-1b32a203bfb213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-593-0167877059301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-593-01) 2020-11-270000-00-00NoNoCurrent
67877-593-0567877059305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-593-05) 2025-02-200000-00-00NoNoCurrent
67877-593-10678770593101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-593-10) 2020-11-270000-00-00NoNoCurrent
67877-593-306787705933030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-593-30) 2020-11-270000-00-00NoNoCurrent
67877-593-606787705936060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-593-60) 2020-11-270000-00-00NoNoCurrent