ALIQOPA

Product NDC
50419-385
11-digit product format
504190385
Labeler code
50419
Product ID
50419-385_dbc41472-e015-4763-b728-b98908319302
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
copanlisib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA209936
Marketing category
NDA
Marketing start
2017-09-14
Marketing end
0000-00-00
Substance
COPANLISIB
Active strength
15 mg/mL
Pharmacologic classes
Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-385-012024-01-30C16284748780-11030e365-6e52-111a-e063-dadaa90a10e2ade50241-2c10-4038-b4e9-72f6bf905f03
50419-385-722024-01-30C16284748780-11030e365-6e52-111a-e063-dadaa90a10e2ade50241-2c10-4038-b4e9-72f6bf905f03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-385-01EA - Each50419-38537e95991-c9af-4433-944b-816a7eee4ab012017-10-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50419-385-01504190385011 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) > 4 mL in 1 VIAL, SINGLE-DOSE2017-09-140000-00-00NoNoCurrent
50419-385-72504190385721 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-72) > 4 mL in 1 VIAL, SINGLE-DOSE2018-10-300000-00-00YesNoCurrent