Varubi

Product NDC
69656-101
11-digit product format
696560101
Labeler code
69656
Product ID
69656-101_41a8662a-8aa7-4c63-8fc6-b29286e08ac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rolapitant
Dosage form
TABLET
Route
ORAL
Labeler
GlaxoSmithLine LLC
Application
NDA206500
Marketing category
NDA
Marketing start
2015-10-07
Marketing end
2021-10-31
Substance
ROLAPITANT HYDROCHLORIDE
Active strength
90 mg/1
Pharmacologic classes
Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69656-101-02EA - Each69656-1015ffbad50-b0ae-4315-9343-f26ec3221ba212015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69656-101-02696560101022 TABLET in 1 BLISTER PACK (69656-101-02) 2 tablet2015-10-072021-10-31NoNoCurrent