FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
72603-143
11-digit product format
726030143
Labeler code
72603
Product ID
72603-143_82de0ba4-1cc6-e9d1-7dc3-844ff6ec1fb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA090617
Marketing category
ANDA
Marketing start
2023-04-10
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
Rxcui866427, 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72603-143-01Metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1003
72603-143-02Metoprolol succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5003
72603-143-03Metoprolol succinate1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-143-01EA - Each72603-1437782000e-4d9a-4827-9b68-f92f43daf88812023-07-06
72603-143-02EA - Each72603-1432dbdacc8-e981-4783-b7b9-7a9fa2e9dcac12023-07-06
72603-143-03EA - Each72603-143c3f582e4-6d32-4fd9-8849-62281de365d812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-143METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]2Current NDC, 3 package rows20230922_ad097646-cc77-8d67-5974-cc00060409f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN114346a1-ce49-49d2-9674-2fa6a49749c35
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN46c288aa-a55c-4207-9a6e-ceef3c2f60ff5
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD114346a1-ce49-49d2-9674-2fa6a49749c35
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD46c288aa-a55c-4207-9a6e-ceef3c2f60ff5
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY114346a1-ce49-49d2-9674-2fa6a49749c35
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY46c288aa-a55c-4207-9a6e-ceef3c2f60ff5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY46c288aa-a55c-4207-9a6e-ceef3c2f60ff5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY114346a1-ce49-49d2-9674-2fa6a49749c35
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNad097646-cc77-8d67-5974-cc00060409f23
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNad097646-cc77-8d67-5974-cc00060409f23
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDad097646-cc77-8d67-5974-cc00060409f23
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDad097646-cc77-8d67-5974-cc00060409f23
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYad097646-cc77-8d67-5974-cc00060409f23
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYad097646-cc77-8d67-5974-cc00060409f23
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYad097646-cc77-8d67-5974-cc00060409f23
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYad097646-cc77-8d67-5974-cc00060409f23
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN32341a31-a2db-cf13-e063-6394a90aad891
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD32341a31-a2db-cf13-e063-6394a90aad891
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY32341a31-a2db-cf13-e063-6394a90aad891
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY32341a31-a2db-cf13-e063-6394a90aad891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-143-0172603014301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-143-01) 2023-04-10NoNoCurrent
72603-143-0272603014302500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-143-02) 2023-04-10NoNoCurrent
72603-143-03726030143031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-143-03) 2023-09-12NoNoCurrent