FOSAPREPITANT DIMEGLUMINE

Product NDC
59651-523
11-digit product format
596510523
Labeler code
59651
Product ID
59651-523_3bb1ce3e-0a57-4363-9c95-e19e8b1d3f33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOSAPREPITANT DIMEGLUMINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Aurobindo Pharma Limited
Application
ANDA210625
Marketing category
ANDA
Marketing start
2021-01-12
Marketing end
0000-00-00
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/5mL
Pharmacologic classes
Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-523-01596510523011 VIAL, SINGLE-DOSE in 1 CARTON (59651-523-01) > 5 mL in 1 VIAL, SINGLE-DOSE2021-01-120000-00-00NoNoCurrent