FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
27808-303
11-digit product format
278080303
Labeler code
27808
Product ID
27808-303_a7845f10-48d0-478b-a760-c1fd208c09b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA207206
Marketing category
ANDA
Marketing start
2025-06-01
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, 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
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
27808-303-01Metoprolol Succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
27808-303-02Metoprolol Succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
27808-303-03Metoprolol Succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-303-01EA - Each27808-303d623b4d5-6beb-4917-b666-7e3af5aa2da612025-07-08
27808-303-02EA - Each27808-30306896cb9-9f71-4d44-ae4e-50d79e7e7c7d12025-07-08
27808-303-03EA - Each27808-30325760d5e-f747-4886-886e-4f59b273db7c12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN8b8cae90-e02a-4a99-81ff-37629c9a42434
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN8b8cae90-e02a-4a99-81ff-37629c9a42434
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN8b8cae90-e02a-4a99-81ff-37629c9a42434
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN8b8cae90-e02a-4a99-81ff-37629c9a42434
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD8b8cae90-e02a-4a99-81ff-37629c9a42434
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD8b8cae90-e02a-4a99-81ff-37629c9a42434
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD8b8cae90-e02a-4a99-81ff-37629c9a42434
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD8b8cae90-e02a-4a99-81ff-37629c9a42434
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY8b8cae90-e02a-4a99-81ff-37629c9a42434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27808-303-0127808030301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-01) 2025-06-01NoNoCurrent
27808-303-0227808030302500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-02) 2025-06-01NoNoCurrent
27808-303-03278080303031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-03) 2025-06-01NoNoCurrent