NDC 0006-3069

PIFELTRO

Doravirine

PIFELTRO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Doravirine.

• Product ID: 0006-3069_113e4ddb-b842-4e29-8391-f7b1520acf79
• NDC: 0006-3069
• Product Type: Human Prescription Drug
• Proprietary Name: PIFELTRO
• Generic Name: Doravirine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-20
• Marketing Category: NDA / NDA
• Application Number: NDA210806
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: DORAVIRINE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0006-3069-01

30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)

• Marketing Start Date: 2018-07-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-3069-01 [00006306901]

PIFELTRO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-20

Drug Details

Active Ingredients

Ingredient	Strength
DORAVIRINE	100 mg/1

OpenFDA Data

• SPL SET ID: 76ce1f00-28c0-4314-bd2c-d473fe3d0970
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 913P6LK81M
• RxNorm Concept Unique ID - RxCUI:
  • 2055766
  • 2055760
• UPC Code:
  • 0300063069014

Pharmacological Class

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

NDC Crossover Matching brand name "PIFELTRO" or generic name "Doravirine"

NDC	Brand Name	Generic Name
0006-3069	PIFELTRO	doravirine
50090-6237	PIFELTRO	doravirine
50090-6268	PIFELTRO	doravirine