FDA.reportPublic FDA data

Intelence

Product NDC
59676-571
11-digit product format
596760571
Labeler code
59676
Product ID
59676-571_02fc6f4f-330d-b32e-e063-6294a90a028a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etravirine
Dosage form
TABLET
Route
ORAL
Labeler
Janssen Products LP
Application
NDA022187
Marketing category
NDA
Marketing start
2010-12-22
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
Intelence
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETRAVIRINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0C50HW4FO1
Rxcui754761, 758555, 1052658, 1052660, 1250721, 1250723

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
59676-571-01Intelence60 in 1 BOTTLE, PLASTICTABLET6024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-571-01EA - Each59676-571c08dae44-333e-4bfb-b0db-efe76c9580ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
etravirineACTIVE INGREDIENT0C50HW4FO1INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
etravirineACTIVE MOIETY0C50HW4FO1INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UINTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
hypromellosesINACTIVE INGREDIENT3NXW29V3WOINTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XINTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
magnesium stearateINACTIVE INGREDIENT70097M6I30INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]13
etravirineACTIVE INGREDIENT0C50HW4FO1INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
etravirineACTIVE MOIETY0C50HW4FO1INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UINTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOINTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XINTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-571INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]24Current NDC, Legacy NDC, 1 package rows20230816_6a9cbc29-9f15-4b24-8d86-206b82887f3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754761etravirine 100 MG Oral TabletPSN6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1052658etravirine 200 MG Oral TabletPSN6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1250721etravirine 25 MG Oral TabletPSN6a9cbc29-9f15-4b24-8d86-206b82887f3d24
758555INTELENCE 100 MG Oral TabletPSN6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1052660INTELENCE 200 MG Oral TabletPSN6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1250723INTELENCE 25 MG Oral TabletPSN6a9cbc29-9f15-4b24-8d86-206b82887f3d24
758555etravirine 100 MG Oral Tablet [Intelence]SBD6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1052660etravirine 200 MG Oral Tablet [Intelence]SBD6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1250723etravirine 25 MG Oral Tablet [Intelence]SBD6a9cbc29-9f15-4b24-8d86-206b82887f3d24
754761etravirine 100 MG Oral TabletSCD6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1052658etravirine 200 MG Oral TabletSCD6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1250721etravirine 25 MG Oral TabletSCD6a9cbc29-9f15-4b24-8d86-206b82887f3d24
758555Intelence 100 MG Oral TabletSY6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1052660Intelence 200 MG Oral TabletSY6a9cbc29-9f15-4b24-8d86-206b82887f3d24
1250723Intelence 25 MG Oral TabletSY6a9cbc29-9f15-4b24-8d86-206b82887f3d24
754761etravirine 100 MG Oral TabletPSN73667241-b95a-49b0-9c51-a4289f20d5c22
1052658etravirine 200 MG Oral TabletPSN73667241-b95a-49b0-9c51-a4289f20d5c22
758555INTELENCE 100 MG Oral TabletPSN73667241-b95a-49b0-9c51-a4289f20d5c22
1052660INTELENCE 200 MG Oral TabletPSN73667241-b95a-49b0-9c51-a4289f20d5c22
758555etravirine 100 MG Oral Tablet [Intelence]SBD73667241-b95a-49b0-9c51-a4289f20d5c22
1052660etravirine 200 MG Oral Tablet [Intelence]SBD73667241-b95a-49b0-9c51-a4289f20d5c22
754761etravirine 100 MG Oral TabletSCD73667241-b95a-49b0-9c51-a4289f20d5c22
1052658etravirine 200 MG Oral TabletSCD73667241-b95a-49b0-9c51-a4289f20d5c22
758555Intelence 100 MG Oral TabletSY73667241-b95a-49b0-9c51-a4289f20d5c22
1052660Intelence 200 MG Oral TabletSY73667241-b95a-49b0-9c51-a4289f20d5c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59676-571-015967605710160 TABLET in 1 BOTTLE, PLASTIC (59676-571-01) 60 tablet2010-12-220000-00-00NoNoCurrent