FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
61919-052
11-digit product format
619190052
Labeler code
61919
Product ID
61919-052_b9458b04-4808-619f-e053-2995a90a729a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076670
Marketing category
ANDA
Marketing start
2019-08-21
Marketing end
0000-00-00
Substance
METOPROLOL TARTRATE
Active strength
25 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 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-052-302024-01-09C16284748780-1f386c64a-27f5-0266-e053-dadaa90a7c1aMETOPROLOL TARTRATE
61919-052-302023-01-30C16284748780-1f386c64a-27f5-0266-e053-dadaa90a7c1aMETOPROLOL TARTRATE
61919-052-602020-01-31C16284748780-19d75b9d0-200e-f424-e053-dadaa90a57ceMETOPROLOL TARTRATE
61919-052-822020-01-31C16284748780-19d75b9d0-200e-f424-e053-dadaa90a57ceMETOPROLOL TARTRATE
61919-052-902020-01-31C16284748780-19d75b9d0-200e-f424-e053-dadaa90a57ceMETOPROLOL TARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-052-60METOPROLOL TARTRATE60 in 1 BOTTLETABLET606
61919-052-82METOPROLOL TARTRATE180 in 1 BOTTLETABLET1806
61919-052-90METOPROLOL TARTRATE90 in 1 BOTTLETABLET906
61919-052-30METOPROLOL TARTRATE30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-052-30EA - Each61919-052d323d47d-dba7-47cd-b5ba-674ad4c0d4c412019-09-05
61919-052-60EA - Each61919-052b14fba86-1454-4938-8880-675fbb1aa17812015-02-02
61919-052-90EA - Each61919-0525baf0610-5cc5-4795-9b34-edec1719de4a12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET [DIRECT RX]2
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET [DIRECT RX]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMETOPROLOL TARTRATE TABLET [DIRECT RX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-052METOPROLOL TARTRATE TABLET [DIRECT RX]6Legacy NDC, 3 package rows20160714_f2152494-0370-492d-9402-4f1368a277c7.zip
61919-052METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE METOPROLOL TARTRATE TABLET [DIRECT_RX]4Legacy NDC, 1 package rows20240110_90a69a79-5517-0ccf-e053-2995a90a441f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSNf2152494-0370-492d-9402-4f1368a277c76
866924metoprolol tartrate 25 MG Oral TabletSCDf2152494-0370-492d-9402-4f1368a277c76
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN90a69a79-5517-0ccf-e053-2995a90a441f4
866924metoprolol tartrate 25 MG Oral TabletPSN90a69a79-5517-0ccf-e053-2995a90a441f4
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD90a69a79-5517-0ccf-e053-2995a90a441f4
866924metoprolol tartrate 25 MG Oral TabletSCD90a69a79-5517-0ccf-e053-2995a90a441f4
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY90a69a79-5517-0ccf-e053-2995a90a441f4
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY90a69a79-5517-0ccf-e053-2995a90a441f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-052-306191900523030 TABLET in 1 BOTTLE (61919-052-30) 30 tablet2019-08-210000-00-00NoNoCurrent
61919-052-606191900526060 in 1 BOTTLEHistorical
61919-052-8261919005282180 in 1 BOTTLEHistorical
61919-052-906191900529090 in 1 BOTTLEHistorical