FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
55111-469
11-digit product format
551110469
Labeler code
55111
Product ID
55111-469_24d7f7ba-6db9-f2f2-fb99-9568f65cd9be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078889
Marketing category
ANDA
Marketing start
2012-09-10
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

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
55111-469-01Metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10010
55111-469-05Metoprolol succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50010
55111-469-30Metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3010
55111-469-60Metoprolol succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6010
55111-469-78Metoprolol succinate10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1010
55111-469-79Metoprolol succinate10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-469-01EA - Each55111-469c346e272-32d7-4c69-94f7-bf035913a9a312013-02-13
55111-469-05EA - Each55111-469d86cf0bd-ccd7-4acd-8308-9b235133fe8c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-469METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC, 6 package rows20220309_71c1d33e-be6f-6d59-b715-45075445891a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN71c1d33e-be6f-6d59-b715-45075445891a10
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN71c1d33e-be6f-6d59-b715-45075445891a10
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD71c1d33e-be6f-6d59-b715-45075445891a10
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD71c1d33e-be6f-6d59-b715-45075445891a10
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY71c1d33e-be6f-6d59-b715-45075445891a10
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY71c1d33e-be6f-6d59-b715-45075445891a10
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY71c1d33e-be6f-6d59-b715-45075445891a10
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY71c1d33e-be6f-6d59-b715-45075445891a10
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN71b27b55-44aa-113d-e053-2995a90a1cf78
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD71b27b55-44aa-113d-e053-2995a90a1cf78
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY71b27b55-44aa-113d-e053-2995a90a1cf78
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN7689f30e-4010-4d7f-b450-9bc1812594951
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN860e0ee0-b24f-4eff-b196-b9b03b37d3d51
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD7689f30e-4010-4d7f-b450-9bc1812594951
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD860e0ee0-b24f-4eff-b196-b9b03b37d3d51
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY7689f30e-4010-4d7f-b450-9bc1812594951
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY860e0ee0-b24f-4eff-b196-b9b03b37d3d51
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY7689f30e-4010-4d7f-b450-9bc1812594951
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY860e0ee0-b24f-4eff-b196-b9b03b37d3d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-469-0155111046901100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-469-01) 2012-09-100000-00-00NoNoCurrent
55111-469-0555111046905500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-469-05) 2012-09-100000-00-00NoNoCurrent
55111-469-305511104693030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-469-30) 2012-09-100000-00-00NoNoCurrent
55111-469-605511104696060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-469-60) 2012-09-100000-00-00NoNoCurrent
55111-469-785511104697810 BLISTER PACK in 1 CARTON (55111-469-78) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (55111-469-79) 10 blister pack2012-09-100000-00-00NoNoCurrent
55111-469-795511104697910 in 1 BLISTER PACKHistorical