NDC 50090-1355

Tivicay

Dolutegravir Sodium

Tivicay is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Dolutegravir Sodium.

• Product ID: 50090-1355_6754b5df-c08e-435f-a87c-30a181cb02af
• NDC: 50090-1355
• Product Type: Human Prescription Drug
• Proprietary Name: Tivicay
• Generic Name: Dolutegravir Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-13
• Marketing Category: NDA / NDA
• Application Number: NDA204790
• Labeler Name: A-S Medication Solutions
• Substance Name: DOLUTEGRAVIR SODIUM
• Active Ingredient Strength: 50 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-1355-0

30 TABLET, FILM COATED in 1 BOTTLE (50090-1355-0)

• Marketing Start Date: 2014-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1355-1 [50090135501]

Tivicay TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204790
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-09
• Marketing End Date: 2018-04-30

NDC 50090-1355-0 [50090135500]

Tivicay TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204790
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-28
• Marketing End Date: 2018-08-31

Drug Details

Active Ingredients

Ingredient	Strength
DOLUTEGRAVIR SODIUM	50 mg/1

OpenFDA Data

• SPL SET ID: 203e09ce-e2b0-489e-9b0a-018690a9813c
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 1Q1V9V5WYQ
• RxNorm Concept Unique ID - RxCUI:
  • 1433879
  • 1433873

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]

NDC Crossover Matching brand name "Tivicay" or generic name "Dolutegravir Sodium"

NDC	Brand Name	Generic Name
49702-226	Tivicay	dolutegravir sodium
49702-227	Tivicay	dolutegravir sodium
49702-228	Tivicay	dolutegravir sodium
50090-1355	Tivicay	dolutegravir sodium
53808-1130	Tivicay	dolutegravir sodium
67296-1818	Tivicay	dolutegravir sodium
70518-1487	Tivicay	dolutegravir sodium
49702-255	Tivicay PD	dolutegravir sodium