FDA.reportPublic FDA data

ETRAVIRINE

Product NDC
80005-113
11-digit product format
800050113
Labeler code
80005
Product ID
80005-113_4b21f36b-78b4-41db-ae59-814076cf5b90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETRAVIRINE
Dosage form
TABLET
Route
ORAL
Labeler
Carnegie Pharmaceuticals LLC
Application
ANDA215402
Marketing category
ANDA
Marketing start
2022-06-07
Substance
ETRAVIRINE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein 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
ETRAVIRINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETRAVIRINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0C50HW4FO1
Rxcui754761, 1052658

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08bcdf9c-0f44-79ee-51ca-e7f77478ea2eProduct name220230112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80005-113-092024-03-05C16284748780-11030e365-394c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008
80005-113-092024-01-30C16284748780-11030e365-394c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80005-113-09ETRAVIRINE60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80005-113ETRAVIRINE TABLET [CARNEGIE PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 1 package rows20240307_154b621d-9a72-489f-9127-55f9bf1797a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754761etravirine 100 MG Oral TabletPSN154b621d-9a72-489f-9127-55f9bf1797a06
1052658etravirine 200 MG Oral TabletPSN154b621d-9a72-489f-9127-55f9bf1797a06
754761etravirine 100 MG Oral TabletSCD154b621d-9a72-489f-9127-55f9bf1797a06
1052658etravirine 200 MG Oral TabletSCD154b621d-9a72-489f-9127-55f9bf1797a06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80005-113-098000501130960 TABLET in 1 BOTTLE (80005-113-09) 60 tablet2022-06-070000-00-00NoNoCurrent