FDA.reportPublic FDA data

EFAVIRENZ

Product NDC
72865-172
11-digit product format
728650172
Labeler code
72865
Product ID
72865-172_f21e4fb1-352d-7105-e053-2995a90a0588
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EFAVIRENZ
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA078886
Marketing category
ANDA
Marketing start
2021-05-29
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
72865-172-25EFAVIRENZ250 in 1 BOTTLETABLET, FILM COATED2502
72865-172-30EFAVIRENZ30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-172-30EA - Each72865-1722e0c4651-f8b1-45c9-8f4c-a2fcc7750fb212021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-172EFAVIRENZ (EFAVIRENZ) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20230113_966b815d-1d78-4b54-8f00-c5a0b67c78be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349477efavirenz 600 MG Oral TabletPSN966b815d-1d78-4b54-8f00-c5a0b67c78be2
349477efavirenz 600 MG Oral TabletSCD966b815d-1d78-4b54-8f00-c5a0b67c78be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-172-2572865017225250 TABLET, FILM COATED in 1 BOTTLE (72865-172-25) 2021-05-290000-00-00NoNoCurrent
72865-172-307286501723030 TABLET, FILM COATED in 1 BOTTLE (72865-172-30) 2021-05-290000-00-00NoNoCurrent