Efavirenz

Product NDC
64980-407
11-digit product format
649800407
Labeler code
64980
Product ID
64980-407_6267ce9b-6ae9-47ae-835c-567963f6477a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Efavirenz
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA078064
Marketing category
ANDA
Marketing start
2017-12-15
Marketing end
0000-00-00
Substance
EFAVIRENZ
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-407-09EA - Each64980-407e2847719-da24-4968-8cff-815c196d00e912018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-407-096498004070990 CAPSULE in 1 BOTTLE (64980-407-09) 90 capsule2017-12-150000-00-00NoNoCurrent