NDC 49702-242

Juluca

Dolutegravir Sodium And Rilpivirine Hydrochloride

Juluca 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; Rilpivirine Hydrochloride.

• Product ID: 49702-242_053c410a-58e9-480e-a911-60a3ec12f688
• NDC: 49702-242
• Product Type: Human Prescription Drug
• Proprietary Name: Juluca
• Generic Name: Dolutegravir Sodium And Rilpivirine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-21
• Marketing Category: NDA / NDA
• Application Number: NDA210192
• Labeler Name: ViiV Healthcare Company
• Substance Name: DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 49702-242-13

30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)

• Marketing Start Date: 2017-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49702-242-13 [49702024213]

Juluca TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-21

Drug Details

Active Ingredients

Ingredient	Strength
DOLUTEGRAVIR SODIUM	50 mg/1

OpenFDA Data

• SPL SET ID: 806653d1-bf35-4924-b999-ad5d21821cc1
• Manufacturer:
  • ViiV Healthcare Company
• UNII:
  • 212WAX8KDD
  • 1Q1V9V5WYQ
• RxNorm Concept Unique ID - RxCUI:
  • 1989500
  • 1989506
• UPC Code:
  • 0349702242135

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

Medicade Reported Pricing

49702024213 JULUCA 50-25 MG TABLET

Pricing Unit: EA | Drug Type: