metoprolol succinate

Product NDC
58177-358
11-digit product format
581770358
Labeler code
58177
Product ID
58177-358_61be400f-687b-4db4-8d15-8a7c1f8318cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Ethex Corporation
Application
ANDA076640
Marketing category
ANDA
Marketing start
2009-11-01
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
190 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-358-04metoprolol succinate extended-release100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001
58177-358-09metoprolol succinate extended-release1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metoprolol succinateACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-358METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]1Legacy NDC, 2 package rows20091124_2d948600-35d8-4490-983b-918bdce488c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN2d948600-35d8-4490-983b-918bdce488c81
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN2d948600-35d8-4490-983b-918bdce488c81
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD2d948600-35d8-4490-983b-918bdce488c81
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD2d948600-35d8-4490-983b-918bdce488c81
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY2d948600-35d8-4490-983b-918bdce488c81
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY2d948600-35d8-4490-983b-918bdce488c81
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY2d948600-35d8-4490-983b-918bdce488c81
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY2d948600-35d8-4490-983b-918bdce488c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58177-358-0458177035804100 in 1 BOTTLEHistorical
58177-358-09581770358091000 in 1 BOTTLEHistorical