FDA.reportPublic FDA data

Magnevist

Product NDC
50419-188
11-digit product format
504190188
Labeler code
50419
Product ID
50419-188_010f5383-4b59-426a-aa4f-674079edb44c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadopentetate dimeglumine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA021037
Marketing category
NDA
Marketing start
2010-12-14
Marketing end
2022-05-30
Substance
GADOPENTETATE DIMEGLUMINE
Active strength
469 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-188-01ML - Milliliter50419-188682363c2-7c43-48c8-91e7-fb9a72c27f8712012-07-24
50419-188-02ML - Milliliter50419-18862685f87-3b33-4ef1-8e99-53fb9696eb4e12012-07-24
50419-188-05ML - Milliliter50419-188d03df8a3-30fc-4f62-ab23-3295935ad75e12012-07-24
50419-188-11ML - Milliliter50419-188be1625a5-a171-4222-98eb-138e010c2e5f12012-07-24
50419-188-15ML - Milliliter50419-1880c33cdc5-db7a-4609-87ef-0ccb3d80773c12012-07-24
50419-188-36ML - Milliliter50419-1881499c965-3142-492d-b9d8-cbac5fc6731812012-07-24
50419-188-37ML - Milliliter50419-18842445aad-09dd-4bd9-ac80-cd06a7c7d32612012-07-24
50419-188-38ML - Milliliter50419-1889c2322cd-09af-44a1-bb73-be9360b6196812012-07-24
50419-188-44ML - Milliliter50419-1881db23299-476d-41a9-9bb7-b5790f88110612015-07-20
50419-188-47ML - Milliliter50419-188f5a42370-0ed0-4dd2-acd9-36597ba57fa812012-07-24
50419-188-58ML - Milliliter50419-1881df490be-14b6-4c4a-a9b9-037a819dde8212012-07-24
50419-188-81ML - Milliliter50419-1886ee0e0b1-6706-44bf-9ca2-1590db2d561d12017-04-05
50419-188-82ML - Milliliter50419-188d92ea7e5-4bdd-4da6-b4b3-1fbcafdf0c7912017-04-05
50419-188-83ML - Milliliter50419-1886a83a07f-16a9-4fe5-839e-6f222297657812017-04-05
50419-188-84ML - Milliliter50419-188dc933313-00e7-47ae-b0ef-a9e9585465ae12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-188-015041901880120 CARTON in 1 BOX (50419-188-01) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-01-31NoNoCurrent
50419-188-025041901880220 CARTON in 1 BOX (50419-188-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-01-31NoNoCurrent
50419-188-055041901880520 CARTON in 1 BOX (50419-188-05) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-07-31NoNoCurrent
50419-188-115041901881110 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-11) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2010-12-142022-05-30NoNoCurrent
50419-188-155041901881520 CARTON in 1 BOX (50419-188-15) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-07-31NoNoCurrent
50419-188-36504190188365 SYRINGE in 1 BOX (50419-188-36) > 10 mL in 1 SYRINGE5 syringe2014-06-112022-02-28NoNoCurrent
50419-188-37504190188375 SYRINGE in 1 BOX (50419-188-37) > 15 mL in 1 SYRINGE5 syringe2014-06-112023-01-31NoNoCurrent
50419-188-38504190188385 SYRINGE in 1 BOX (50419-188-38) > 20 mL in 1 SYRINGE5 syringe2014-06-112022-10-30NoNoCurrent
50419-188-405041901884020 CARTON in 1 BOX (50419-188-40) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-07-31NoNoCurrent
50419-188-425041901884220 CARTON in 1 BOX (50419-188-42) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-01-31NoNoCurrent
50419-188-43504190188435 SYRINGE in 1 BOX (50419-188-43) > 10 mL in 1 SYRINGE5 syringe2014-06-112022-02-28NoNoCurrent
50419-188-445041901884420 CARTON in 1 BOX (50419-188-44) > 20 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-07-31NoNoCurrent
50419-188-45504190188455 SYRINGE in 1 BOX (50419-188-45) > 15 mL in 1 SYRINGE5 syringe2014-06-112023-01-31NoNoCurrent
50419-188-465041901884620 CARTON in 1 BOX (50419-188-46) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE20 carton2014-06-112022-01-31NoNoCurrent
50419-188-47504190188475 SYRINGE in 1 BOX (50419-188-47) > 20 mL in 1 SYRINGE5 syringe2014-06-112022-10-30NoNoCurrent
50419-188-585041901885810 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-58) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE2010-12-142022-05-30NoNoCurrent
50419-188-81504190188812 CARTON in 1 BOX (50419-188-81) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE2 carton2016-06-012022-07-31NoNoCurrent
50419-188-82504190188822 CARTON in 1 BOX (50419-188-82) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE2 carton2016-06-012022-01-31NoNoCurrent
50419-188-83504190188832 CARTON in 1 BOX (50419-188-83) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE2 carton2016-06-012022-07-31NoNoCurrent
50419-188-84504190188842 CARTON in 1 BOX (50419-188-84) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE2 carton2016-06-012022-01-31NoNoCurrent