FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
0904-6323
11-digit product format
009046323
Labeler code
0904
Product ID
0904-6323_fb44a568-5b01-45b0-a72d-6eed8ee087dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

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
0904-6323-61Metoprolol succinate1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE113
0904-6323-61Metoprolol succinate100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6323-61EA - Each0904-6323b74d5d5b-821d-405b-b5a0-a78ad2b0855912013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6323METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]10Current NDC, Legacy NDC, 2 package rows20250418_14ab9921-4651-4abc-92dc-aab1719b6bb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN14ab9921-4651-4abc-92dc-aab1719b6bb013
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN14ab9921-4651-4abc-92dc-aab1719b6bb013
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD14ab9921-4651-4abc-92dc-aab1719b6bb013
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD14ab9921-4651-4abc-92dc-aab1719b6bb013
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY14ab9921-4651-4abc-92dc-aab1719b6bb013
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY14ab9921-4651-4abc-92dc-aab1719b6bb013
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY14ab9921-4651-4abc-92dc-aab1719b6bb013
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY14ab9921-4651-4abc-92dc-aab1719b6bb013
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNe2f8dd23-600f-460e-aced-4e13504628f19
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDe2f8dd23-600f-460e-aced-4e13504628f19
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYe2f8dd23-600f-460e-aced-4e13504628f19
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYe2f8dd23-600f-460e-aced-4e13504628f19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6323-6100904632361100 BLISTER PACK in 1 CARTON (0904-6323-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2012-09-100000-00-00NoNoCurrent