FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
42543-001
11-digit product format
425430001
Labeler code
42543
Product ID
42543-001_11be6622-286f-4d42-98b8-876daace162c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA200981
Marketing category
ANDA
Marketing start
2015-08-14
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42543-001-012020-01-31C16284748780-19d75b9d1-1230-f424-e053-dadaa90a57ceMETOPROLOL TARTRATE - metoprolol tartrate tablet, film coated Vensun Pharmaceuticals, Inc. R x only
42543-001-102020-01-31C16284748780-19d75b9d1-1230-f424-e053-dadaa90a57ceMETOPROLOL TARTRATE - metoprolol tartrate tablet, film coated Vensun Pharmaceuticals, Inc. R x only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42543-001-01Metoprolol Tartrate100 in 1 BOTTLETABLET, FILM COATED1004
42543-001-10Metoprolol Tartrate1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-001-01EA - Each42543-001f7ca082d-9a37-46be-8f4d-86401586f9bf12015-11-12
42543-001-10EA - Each42543-001c1326cea-ac13-4a6a-ba00-e014c8b86e6512015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-001METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED METOPROLOL TARTRATE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20180810_1daa1441-c71d-064f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN7e9e5e82-10fa-4e9b-b57c-3ec85b05c0465
866924metoprolol tartrate 25 MG Oral TabletPSN7e9e5e82-10fa-4e9b-b57c-3ec85b05c0465
866514metoprolol tartrate 50 MG Oral TabletPSN7e9e5e82-10fa-4e9b-b57c-3ec85b05c0465
866511metoprolol tartrate 100 MG Oral TabletSCD7e9e5e82-10fa-4e9b-b57c-3ec85b05c0465
866924metoprolol tartrate 25 MG Oral TabletSCD7e9e5e82-10fa-4e9b-b57c-3ec85b05c0465
866514metoprolol tartrate 50 MG Oral TabletSCD7e9e5e82-10fa-4e9b-b57c-3ec85b05c0465
866511metoprolol tartrate 100 MG Oral TabletPSN1daa1441-c71d-064f-e054-00144ff8d46c4
866924metoprolol tartrate 25 MG Oral TabletPSN1daa1441-c71d-064f-e054-00144ff8d46c4
866514metoprolol tartrate 50 MG Oral TabletPSN1daa1441-c71d-064f-e054-00144ff8d46c4
866511metoprolol tartrate 100 MG Oral TabletSCD1daa1441-c71d-064f-e054-00144ff8d46c4
866924metoprolol tartrate 25 MG Oral TabletSCD1daa1441-c71d-064f-e054-00144ff8d46c4
866514metoprolol tartrate 50 MG Oral TabletSCD1daa1441-c71d-064f-e054-00144ff8d46c4
866924metoprolol tartrate 25 MG Oral TabletPSNed165a1b-13c0-4093-bcaf-a3b3d78563932
866924metoprolol tartrate 25 MG Oral TabletSCDed165a1b-13c0-4093-bcaf-a3b3d78563932
866924metoprolol tartrate 25 MG Oral TabletPSNed9dc8c4-3663-48b2-8a28-32519573b4571
866924metoprolol tartrate 25 MG Oral TabletSCDed9dc8c4-3663-48b2-8a28-32519573b4571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42543-001-0142543000101100 in 1 BOTTLEHistorical
42543-001-10425430001101000 in 1 BOTTLEHistorical