NDC 49702-246

Dovato

Dolutegravir Sodium And Lamivudine

Dovato is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Viiv Healthcare Company. The primary component is Dolutegravir Sodium; Lamivudine.

• Product ID: 49702-246_0e64f2da-3afc-4327-9b4b-08f4e432c6cd
• NDC: 49702-246
• Product Type: Human Prescription Drug
• Proprietary Name: Dovato
• Generic Name: Dolutegravir Sodium And Lamivudine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-08
• Marketing Category: NDA / NDA
• Application Number: NDA211994
• Labeler Name: ViiV Healthcare Company
• Substance Name: DOLUTEGRAVIR SODIUM; LAMIVUDINE
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],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]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 49702-246-13

30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)

• Marketing Start Date: 2019-04-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49702-246-61 [49702024661]

Dovato TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211994
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-06

NDC 49702-246-13 [49702024613]

Dovato TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211994
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-08

Drug Details

Active Ingredients

Ingredient	Strength
DOLUTEGRAVIR SODIUM	50 mg/1

OpenFDA Data

• SPL SET ID: 68e45422-43ed-4cfb-9356-fae88d14a53a
• Manufacturer:
  • ViiV Healthcare Company
• UNII:
  • 2T8Q726O95
  • 1Q1V9V5WYQ

Pharmacological Class

• HIV Integrase Inhibitors [MoA]
• Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
• Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]
• Organic Cation Transporter 2 Inhibitors [MoA]
• 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]