Fosaprepitant

Product NDC
0781-3497
11-digit product format
007813497
Labeler code
0781
Product ID
0781-3497_bc13224c-e27f-4bfe-8cba-aae434fbda0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
ANDA212309
Marketing category
ANDA
Marketing start
2020-09-02
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3497-75007813497751 VIAL, SINGLE-DOSE in 1 CARTON (0781-3497-75) > 5 mL in 1 VIAL, SINGLE-DOSE2020-09-020000-00-00NoNoCurrent