Metoprolol Succinate

Product NDC
63187-546
11-digit product format
631870546
Labeler code
63187
Product ID
63187-546_de8da502-e219-420e-b886-1d8125c8bb12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076862
Marketing category
ANDA
Marketing start
2009-08-04
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-546METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Legacy NDC20210114_2e1edf39-0269-4d32-8583-28c2640f3193.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-546-306318705463030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-546-30) 2018-12-010000-00-00NoNoCurrent
63187-546-606318705466060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-546-60) 2018-12-010000-00-00NoNoCurrent
63187-546-906318705469090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-546-90) 2018-12-010000-00-00NoNoCurrent