NDC 59676-278

EDURANT

Rilpivirine Hydrochloride

EDURANT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Products, Lp. The primary component is Rilpivirine Hydrochloride.

• Product ID: 59676-278_0823bccc-f79a-400b-a8bf-8e0988f7a158
• NDC: 59676-278
• Product Type: Human Prescription Drug
• Proprietary Name: EDURANT
• Generic Name: Rilpivirine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-05-20
• Marketing Category: NDA / NDA
• Application Number: NDA202022
• Labeler Name: Janssen Products, LP
• Substance Name: RILPIVIRINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1
• Pharm 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: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 59676-278-01

30 TABLET, FILM COATED in 1 BOTTLE (59676-278-01)

• Marketing Start Date: 2011-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-278-01 [59676027801]

EDURANT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202022
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-05-20

Drug Details

Active Ingredients

Ingredient	Strength
RILPIVIRINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: 03880372-2c68-45c6-a53a-f420c49541d6
• Manufacturer:
  • Janssen Products, LP
• UNII:
  • 212WAX8KDD
• RxNorm Concept Unique ID - RxCUI:
  • 1102277
  • 1102273
• UPC Code:
  • 0359676278016

Pharmacological Class

• Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Non-Nucleoside Analog [EXT]

Medicade Reported Pricing

59676027801 EDURANT 25 MG TABLET

Pricing Unit: EA | Drug Type: