NDC 59676-280-01 - EDURANT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59676-280
Requested NDC
59676-280-01
Package NDCs from labels
59676-280-01, 59676-280-90
Manufacturer
Janssen Products, LP | AndersonBrecon Inc | Janssen Pharmaceutica NV | Janssen-Cilag SpA | Johnson & Johnson Private Limited | Janssen Pharmaceutical Sciences Unlimited Company
Effective date
2025-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EDURANTJanssen Products, LP | AndersonBrecon Inc | Janssen Pharmaceutica NV | Janssen-Cilag SpA | Johnson & Johnson Private Limited | Janssen Pharmaceutical Sciences Unlimited Company2025-08-28HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 42 of 130 · 2,585 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
unii: 15FIX9V2JP
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
unii: 15FIX9V2JP
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
unii: 15FIX9V2JP
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.