FDA.reportPublic FDA data

Efavirenz

Product NDC
33342-013
11-digit product format
333420013
Labeler code
33342
Product ID
33342-013_f1a4251a-e04d-48aa-ae58-44b30df1de0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Efavirenz
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA091579
Marketing category
ANDA
Marketing start
2024-05-10
Substance
EFAVIRENZ
Active strength
600 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Efavirenz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFAVIRENZ600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE6H2O27P8
Rxcui349477

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
649b204e-4c3b-7f17-657b-ae3f2995e611Product name720250220
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0bProduct name120180221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-013-07Efavirenz30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-013EFAVIRENZ TABLET [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 1 package rows20240630_13ca3456-e5bf-4bb1-af95-b1378658a358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349477efavirenz 600 MG Oral TabletPSN13ca3456-e5bf-4bb1-af95-b1378658a3582
349477efavirenz 600 MG Oral TabletSCD13ca3456-e5bf-4bb1-af95-b1378658a3582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-013-073334200130730 TABLET in 1 BOTTLE (33342-013-07) 30 tablet2024-05-10NoNoHistorical