FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
68001-120
11-digit product format
680010120
Labeler code
68001
Product ID
68001-120_1aeaf7d4-6a9a-49c8-8e09-6f4411462ee4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078889
Marketing category
ANDA
Marketing start
2013-11-25
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
68001-120-00Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
68001-120-03Metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-120-00EA - Each68001-1203a488285-73ab-45c4-a0dc-c03678bb2d9312014-01-04
68001-120-03EA - Each68001-120ff089656-b37e-4bf1-9521-89437d9124ec12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-120METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 2 package rows20190326_5ef12832-15cd-40f4-bf11-6cea7e48ff7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY5ef12832-15cd-40f4-bf11-6cea7e48ff7f7
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY5ef12832-15cd-40f4-bf11-6cea7e48ff7f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-120-0068001012000100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-120-00) 2013-11-250000-00-00NoNoCurrent
68001-120-0368001012003500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-120-03) 2013-11-250000-00-00NoNoCurrent