NDC 53808-0787

Intelence

Etravirine

Intelence is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Etravirine.

• Product ID: 53808-0787_4eae84af-ae77-47c6-ade9-e78a26d33b59
• NDC: 53808-0787
• Product Type: Human Prescription Drug
• Proprietary Name: Intelence
• Generic Name: Etravirine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA022187
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: ETRAVIRINE
• Active Ingredient Strength: 100 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53808-0787-1

30 TABLET in 1 BLISTER PACK (53808-0787-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0787-1 [53808078701]

Intelence TABLET

• Marketing Category: NDA
• Application Number: NDA022187
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ETRAVIRINE	100 mg/1

OpenFDA Data

• SPL SET ID: 1b5a2dc7-0570-4977-876d-88b4176844a1
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 0C50HW4FO1
• RxNorm Concept Unique ID - RxCUI:
  • 754761
  • 758555
• UPC Code:
  • 0359676570011

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