Fosaprepitant

Product NDC
69539-034
11-digit product format
695390034
Labeler code
69539
Product ID
69539-034_1ace4714-01cd-47be-8c71-f08093c20862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA209965
Marketing category
ANDA
Marketing start
2019-09-05
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69539-034-012025-11-20C16284748780-12cef2736-9292-d83d-e063-dadaa90ab31f1f80f069-0796-4540-a2f3-2e33d592da6c
69539-034-012025-01-30C16284748780-12cef2736-9292-d83d-e063-dadaa90ab31f1f80f069-0796-4540-a2f3-2e33d592da6c

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-034FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MSN LABORATORIES PRIVATE LIMITED]8Legacy NDC20191228_1f80f069-0796-4540-a2f3-2e33d592da6c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69539-034-01695390034011 VIAL, SINGLE-DOSE in 1 CARTON (69539-034-01) > 5 mL in 1 VIAL, SINGLE-DOSE2019-09-050000-00-00NoNoCurrent