NDC 0006-5007

DELSTRIGO

Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate

DELSTRIGO 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; Lamivudine; Tenofovir Disoproxil Fumarate.

• Product ID: 0006-5007_11f125b6-a409-4d0e-af3c-410692bbcca6
• NDC: 0006-5007
• Product Type: Human Prescription Drug
• Proprietary Name: DELSTRIGO
• Generic Name: Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-20
• Marketing Category: NDA / NDA
• Application Number: NDA210807
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
• Active Ingredient Strength: 100 mg/1; mg/1; 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],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0006-5007-01

30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)

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

NDC SPL Data Element Entries

NDC 0006-5007-01 [00006500701]

DELSTRIGO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210807
• 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: cd1e9f84-607a-46d3-b01e-2736018d67b6
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 913P6LK81M
  • OTT9J7900I
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 2055815
  • 2055813
• UPC Code:
  • 0300065007014

Pharmacological Class

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