edurant ped

Generic: rilpivirine hydrochloride

Labeler: janssen products, lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name edurant ped
Generic Name rilpivirine hydrochloride
Labeler janssen products, lp
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

rilpivirine hydrochloride 2.5 mg/1

Manufacturer
Janssen Products, LP

Identifiers & Regulatory

Product NDC 59676-280
Product ID 59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219016
Listing Expiration 2026-12-31
Marketing Start 2024-03-15

Pharmacologic Class

Classes
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc] non-nucleoside analog [ext] non-nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676280
Hyphenated Format 59676-280

Supplemental Identifiers

RxCUI
1102273 1102277 2678244 2678248
UPC
0359676278016
UNII
212WAX8KDD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name edurant ped (source: ndc)
Generic Name rilpivirine hydrochloride (source: ndc)
Application Number NDA219016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)
source: ndc

Packages (1)

59676-280-90 9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)

Ingredients (1)

rilpivirine hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

EDURANT, EDURANT PED ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d6d0fcc-0b62-b76b-e063-6294a90aea43", "openfda": {"upc": ["0359676278016"], "unii": ["212WAX8KDD"], "rxcui": ["1102273", "1102277", "2678244", "2678248"], "spl_set_id": ["03880372-2c68-45c6-a53a-f420c49541d6"], "manufacturer_name": ["Janssen Products, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "9 BLISTER PACK in 1 CARTON (59676-280-90)  / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)", "package_ndc": "59676-280-90", "marketing_start_date": "20240315"}], "brand_name": "EDURANT PED", "product_id": "59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "59676-280", "generic_name": "rilpivirine hydrochloride", "labeler_name": "Janssen Products, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EDURANT PED", "active_ingredients": [{"name": "RILPIVIRINE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "NDA219016", "marketing_category": "NDA", "marketing_start_date": "20240315", "listing_expiration_date": "20261231"}