FDA.reportPublic FDA data

fosaprepitant

Product NDC
67457-888
11-digit product format
674570888
Labeler code
67457
Product ID
67457-888_65e4e7f1-6ca9-4138-ad88-38f530abac3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA204015
Marketing category
ANDA
Marketing start
2019-09-05
Marketing end
0000-00-00
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
115 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67457-888-102025-07-16C16284748780-1f386c64a-182a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
67457-888-102025-07-16C16284748780-1f386c64a-182a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
67457-888-102023-01-30C16284748780-1f386c64a-182a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
67457-888-102023-01-30C16284748780-1f386c64a-182a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-888FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]2Legacy NDC20200404_9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a.zip