FDA.reportPublic FDA data

Efavirenz

Product NDC
65862-049
11-digit product format
658620049
Labeler code
65862
Product ID
65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Efavirenz
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077673
Marketing category
ANDA
Marketing start
2018-09-21
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
65862-049-10Efavirenz3 in 1 CARTONTABLET, FILM COATED310
65862-049-10Efavirenz10 in 1 BLISTER PACKTABLET, FILM COATED1010
65862-049-30Efavirenz30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-049-30EA - Each65862-0490592e188-cf40-42e8-99ce-9d4d721c8bd712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-049EFAVIRENZ TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 3 package rows20240104_c5eedb5d-4cab-4056-a14a-ffdf67701355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349477efavirenz 600 MG Oral TabletPSNc5eedb5d-4cab-4056-a14a-ffdf6770135510
349477efavirenz 600 MG Oral TabletSCDc5eedb5d-4cab-4056-a14a-ffdf6770135510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-049-10658620049103 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-09-210000-00-00NoNoCurrent
65862-049-15658620049151500 TABLET, FILM COATED in 1 BAG (65862-049-15)21-SEP-18Current
65862-049-306586200493030 TABLET, FILM COATED in 1 BOTTLE (65862-049-30) 2018-09-210000-00-00NoNoCurrent
65862-049-99658620049991000 TABLET, FILM COATED in 1 BAG (65862-049-99)21-SEP-18Current