FDA.reportPublic FDA data

EDURANT PED

Product NDC
59676-280
11-digit product format
596760280
Labeler code
59676
Product ID
59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rilpivirine hydrochloride
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Janssen Products, LP
Application
NDA219016
Marketing category
NDA
Marketing start
2024-03-15
Substance
RILPIVIRINE HYDROCHLORIDE
Active strength
2.5 mg/1
Pharmacologic classes
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
EDURANT PED
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RILPIVIRINE HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii212WAX8KDD
Rxcui1102273, 1102277, 2678244, 2678248

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
38d19fab-47e8-d825-5329-4948eaa6d686Product name220250124
f306ec07-0d7d-45ce-ade0-e6c8659560b1Product name120210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
44633898-5724-4273-abcc-3541a1107946Product name120180124
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-280-01EDURANT PED10 in 1 BLISTER PACKTABLET, FOR SUSPENSION1028
59676-280-90EDURANT PED9 in 1 CARTONTABLET, FOR SUSPENSION928

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-280-01EA - Each59676-280d0a0ff69-020d-448d-97ab-4cf4f0e552ba12025-06-13
59676-280-90EA - Each59676-280b4be1cfb-bc46-4882-beac-cc479e2757cc12025-06-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rilpivirine hydrochlorideACTIVE INGREDIENT212WAX8KDDEDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
rilpivirineACTIVE MOIETYFI96A8X663EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHEDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XEDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11
TRIACETININACTIVE INGREDIENTXHX3C3X673EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-280EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED EDURANT PED (RILPIVIRINE HYDROCHLORIDE) TABLET, FOR SUSPENSION [JANSSEN PRODUCTS, LP]27Current NDC, 2 package rows20250210_03880372-2c68-45c6-a53a-f420c49541d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2678248EDURANT 2.5 MG Tablet for Oral SuspensionPSN03880372-2c68-45c6-a53a-f420c49541d628
1102277EDURANT 25 MG Oral TabletPSN03880372-2c68-45c6-a53a-f420c49541d628
2678244rilpivirine 2.5 MG Tablet for Oral SuspensionPSN03880372-2c68-45c6-a53a-f420c49541d628
1102273rilpivirine 25 MG Oral TabletPSN03880372-2c68-45c6-a53a-f420c49541d628
2678248rilpivirine 2.5 MG Tablet for Oral Suspension [Edurant]SBD03880372-2c68-45c6-a53a-f420c49541d628
1102277rilpivirine 25 MG Oral Tablet [Edurant]SBD03880372-2c68-45c6-a53a-f420c49541d628
2678244rilpivirine 2.5 MG Tablet for Oral SuspensionSCD03880372-2c68-45c6-a53a-f420c49541d628
1102273rilpivirine 25 MG Oral TabletSCD03880372-2c68-45c6-a53a-f420c49541d628
2678248Edurant 2.5 MG (rilpivirine hydrochloride 2.75 MG) Tablet for Oral SuspensionSY03880372-2c68-45c6-a53a-f420c49541d628
2678248Edurant 2.5 MG Tablet for Oral SuspensionSY03880372-2c68-45c6-a53a-f420c49541d628
1102277Edurant 25 MG (rilpivirine hydrochloride 27.5 MG) Oral TabletSY03880372-2c68-45c6-a53a-f420c49541d628
1102277Edurant 25 MG Oral TabletSY03880372-2c68-45c6-a53a-f420c49541d628
2678244rilpivirine 2.5 MG (rilpivirine hydrochloride 2.75 MG) Tablet for Oral SuspensionSY03880372-2c68-45c6-a53a-f420c49541d628
1102273rilpivirine 25 MG (rilpivirine hydrochloride 27.5 MG) Oral TabletSY03880372-2c68-45c6-a53a-f420c49541d628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59676-280-015967602800110 in 1 BLISTER PACKHistorical
59676-280-90596760280909 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01) 9 blister pack2024-03-15NoNoCurrent