NDC 59676-572

Intelence

Etravirine

Intelence is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Janssen Products Lp. The primary component is Etravirine.

• Product ID: 59676-572_1838a50c-09c7-11ea-828e-5629192adfa6
• NDC: 59676-572
• Product Type: Human Prescription Drug
• Proprietary Name: Intelence
• Generic Name: Etravirine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-03-26
• Marketing Category: NDA / NDA
• Application Number: NDA022187
• Labeler Name: Janssen Products LP
• Substance Name: ETRAVIRINE
• 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: 2021-12-31

Packaging

NDC 59676-572-01

120 TABLET in 1 BOTTLE, PLASTIC (59676-572-01)

• Marketing Start Date: 2012-03-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-572-01 [59676057201]

Intelence TABLET

• Marketing Category: NDA
• Application Number: NDA022187
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-03-26

Drug Details

Active Ingredients

Ingredient	Strength
ETRAVIRINE	25 mg/1

OpenFDA Data

• SPL SET ID: 6a9cbc29-9f15-4b24-8d86-206b82887f3d
• Manufacturer:
  • Janssen Products LP
• UNII:
  • 0C50HW4FO1
• RxNorm Concept Unique ID - RxCUI:
  • 754761
  • 758555
  • 1250723
  • 1052658
  • 1052660
  • 1250721
• UPC Code:
  • 0359676572015

Pharmacological Class

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

NDC Crossover Matching brand name "Intelence" or generic name "Etravirine"

NDC	Brand Name	Generic Name
53808-0787	Intelence	Etravirine
59676-570	Intelence	etravirine
59676-571	Intelence	etravirine
59676-572	Intelence	etravirine
42291-473	etravirine	etravirine
42291-474	etravirine	etravirine
60219-1720	etravirine	etravirine
60219-1721	etravirine	etravirine
60219-1722	etravirine	etravirine
69238-1720	etravirine	etravirine
69238-1721	etravirine	etravirine
69238-1722	etravirine	etravirine
69315-285	ETRAVIRINE	ETRAVIRINE
69315-286	ETRAVIRINE	ETRAVIRINE
80005-112	ETRAVIRINE	ETRAVIRINE
80005-113	ETRAVIRINE	ETRAVIRINE