FDA.reportPublic FDA data

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 4 of 132 · 2,632 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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