Efavirenz

Product NDC
0378-2233
11-digit product format
003782233
Labeler code
0378
Product ID
0378-2233_4de5ffbd-5845-4cbc-8c08-0ba69d97b9bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
efavirenz
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA091471
Marketing category
ANDA
Marketing start
2018-01-30
Marketing end
2023-01-31
Substance
EFAVIRENZ
Active strength
600 mg/1
Pharmacologic classes
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 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
0378-2233-93EA - Each0378-2233a666518c-3531-4510-a008-2937ea5fe88312018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-2233-930037822339330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2233-93) 2018-01-302023-01-31NoNoCurrent