Bortezomib

Product NDC
50742-484
11-digit product format
507420484
Labeler code
50742
Product ID
50742-484_125ff955-0078-4a7e-a4d9-80739bcf302c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bortezomib
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA210824
Marketing category
ANDA
Marketing start
2022-05-01
Marketing end
0000-00-00
Substance
BORTEZOMIB
Active strength
4 mg/1
Pharmacologic classes
Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-484-01EA - Each50742-484834c6450-40e4-468a-aea5-39aa61f61c4012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-484BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INGENUS PHARMACEUTICALS, LLC]3Legacy NDC20231229_c9bf8425-afa5-4171-b114-d83acb6d526d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-484-01507420484011 VIAL in 1 CARTON (50742-484-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2022-05-010000-00-00NoNoCurrent