Metoprolol Succinate

Product NDC
43353-583
11-digit product format
433530583
Labeler code
43353
Product ID
43353-583_f3ee686a-e28c-4af6-b06d-e90642ab6442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
2019-12-31
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
43353-583-30Metoprolol Succinate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301
43353-583-45Metoprolol Succinate45 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE451
43353-583-60Metoprolol Succinate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-583-30EA - Each43353-5831b98474d-579b-4643-a57a-ee43acbf17dc12014-06-03
43353-583-45EA - Each43353-583987e7fae-c6bb-4860-8e0a-4923f7f5edea12014-06-03
43353-583-60EA - Each43353-5835246ef9b-f84d-4f23-b6d1-1867851edd6f12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-583METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20140521_1b369f44-bb31-4eca-8d98-025ad18c28d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN1b369f44-bb31-4eca-8d98-025ad18c28d51
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN1b369f44-bb31-4eca-8d98-025ad18c28d51
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD1b369f44-bb31-4eca-8d98-025ad18c28d51
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD1b369f44-bb31-4eca-8d98-025ad18c28d51
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY1b369f44-bb31-4eca-8d98-025ad18c28d51
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY1b369f44-bb31-4eca-8d98-025ad18c28d51
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY1b369f44-bb31-4eca-8d98-025ad18c28d51
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY1b369f44-bb31-4eca-8d98-025ad18c28d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-583-304335305833030 in 1 BOTTLE, PLASTICHistorical
43353-583-454335305834545 in 1 BOTTLE, PLASTICHistorical
43353-583-604335305836090 in 1 BOTTLE, PLASTICHistorical