NDC 49702-226

Tivicay

Dolutegravir Sodium

Tivicay 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.

• Product ID: 49702-226_12d2a862-eacf-4ebe-a7da-4ed20faef568
• NDC: 49702-226
• Product Type: Human Prescription Drug
• Proprietary Name: Tivicay
• Generic Name: Dolutegravir Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-09
• Marketing Category: NDA / NDA
• Application Number: NDA204790
• Labeler Name: ViiV Healthcare Company
• Substance Name: DOLUTEGRAVIR SODIUM
• Active Ingredient Strength: 10 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: 2020-12-31

Packaging

NDC 49702-226-13

30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)

• Marketing Start Date: 2016-06-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49702-226-13 [49702022613]

Tivicay TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-09

Drug Details

Active Ingredients

Ingredient	Strength
DOLUTEGRAVIR SODIUM	10 mg/1

OpenFDA Data

• SPL SET ID: 63df5af3-b8ac-4e76-9830-2dbb340af922
• Manufacturer:
  • ViiV Healthcare Company
• UNII:
  • 1Q1V9V5WYQ
• RxNorm Concept Unique ID - RxCUI:
  • 1433873
  • 1433879
  • 1796077
  • 1796079
  • 1796081
  • 1796083
• UPC Code:
  • 0349702226135
  • 0349702227132
  • 0349702228139

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