FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
60687-402
11-digit product format
606870402
Labeler code
60687
Product ID
60687-402_22027775-f0b5-c7f5-e063-6394a90a25f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090617
Marketing category
ANDA
Marketing start
2018-12-07
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, 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
60687-402-01Metoprolol Succinate100 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1007
60687-402-11Metoprolol Succinate1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE17
60687-402-65Metoprolol Succinate50 in 1 CARTONTABLET, EXTENDED RELEASE507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-402-01EA - Each60687-402e74729ca-8397-405e-9e73-2ac6dda4040412018-12-13
60687-402-11EA - Each60687-40204b2efb9-0ec2-4f80-a05d-fd6142a93be912018-12-13
60687-402-65EA - Each60687-402dfa0fa8f-8ed0-40de-9b25-38f4a1d37cb012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-402METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 3 package rows20240915_74e3b4dc-eb30-4d7c-a558-cf58f6470496.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN74e3b4dc-eb30-4d7c-a558-cf58f64704967
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN74e3b4dc-eb30-4d7c-a558-cf58f64704967
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN74e3b4dc-eb30-4d7c-a558-cf58f64704967
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD74e3b4dc-eb30-4d7c-a558-cf58f64704967
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD74e3b4dc-eb30-4d7c-a558-cf58f64704967
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD74e3b4dc-eb30-4d7c-a558-cf58f64704967
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY74e3b4dc-eb30-4d7c-a558-cf58f64704967
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY74e3b4dc-eb30-4d7c-a558-cf58f64704967
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY74e3b4dc-eb30-4d7c-a558-cf58f64704967
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY74e3b4dc-eb30-4d7c-a558-cf58f64704967
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY74e3b4dc-eb30-4d7c-a558-cf58f64704967
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY74e3b4dc-eb30-4d7c-a558-cf58f64704967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-402-0160687040201100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-402-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-402-11) 100 blister pack2018-12-070000-00-00NoNoCurrent
60687-402-11606870402111 in 1 BLISTER PACKHistorical
60687-402-656068704026550 BLISTER PACK in 1 CARTON (60687-402-65) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-402-11) 50 blister pack2023-03-08NoNoHistorical