fosaprepitant

Product NDC
69097-830
11-digit product format
690970830
Labeler code
69097
Product ID
69097-830_5d828458-1e4f-4e36-9e9f-74c846722b04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA212309
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38eProduct name720240514
5d352eda-d4de-4572-9a3f-32d6fd204f9aProduct name120230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4Product name120230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6Product name420210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568Product name120180108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-830-37EA - Each69097-8308ac61e21-983e-4ffa-acf2-28aff0340d3112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-830FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.]2Legacy NDC20210217_cb36d3fb-4e13-4953-961d-b0e353c94942.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-830-37690970830371 VIAL, SINGLE-DOSE in 1 CARTON (69097-830-37) > 5 mL in 1 VIAL, SINGLE-DOSE2019-09-050000-00-00NoNoCurrent