Etravirine

Product NDC
10147-0570
11-digit product format
101470570
Labeler code
10147
Product ID
10147-0570_31cddc7a-0154-c49a-e063-6394a90a1a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etravirine
Dosage form
TABLET
Route
ORAL
Labeler
Patriot Pharmaceuticals
Application
NDA022187
Marketing category
NDA
Marketing start
2025-04-01
Substance
ETRAVIRINE
Active strength
100 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
ETRAVIRINE100 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10147-0570-1Etravirine120 in 1 BOTTLE, PLASTICTABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10147-0570-1EA - Each10147-0570befdd114-1f5f-4291-9d7e-9d2754c5ac9612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10147-0570ETRAVIRINE TABLET [PATRIOT PHARMACEUTICALS]3Current NDC, 1 package rows20250406_50ca19cb-0f43-4d7b-8c9e-8b3aaded0546.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754761etravirine 100 MG Oral TabletPSN50ca19cb-0f43-4d7b-8c9e-8b3aaded05463
1052658etravirine 200 MG Oral TabletPSN50ca19cb-0f43-4d7b-8c9e-8b3aaded05463
754761etravirine 100 MG Oral TabletSCD50ca19cb-0f43-4d7b-8c9e-8b3aaded05463
1052658etravirine 200 MG Oral TabletSCD50ca19cb-0f43-4d7b-8c9e-8b3aaded05463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10147-0570-110147057001120 TABLET in 1 BOTTLE, PLASTIC (10147-0570-1) 120 tablet2025-04-01NoNoHistorical