Tivicay

Product NDC
70518-1487
11-digit product format
705181487
Labeler code
70518
Product ID
70518-1487_d9646621-c67e-490a-e053-2995a90a2a4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dolutegravir sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA204790
Marketing category
NDA
Marketing start
2018-10-06
Marketing end
0000-00-00
Substance
DOLUTEGRAVIR SODIUM
Active strength
50 mg/1
Pharmacologic classes
HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1487-07051814870030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1487-0) 2018-10-060000-00-00NoNoCurrent