NDC 53808-1130

Tivicay

Dolutegravir Sodium

Tivicay is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Doh Central Pharmacy. The primary component is Dolutegravir Sodium.

• Product ID: 53808-1130_51db3b9b-9a78-4c16-ad8e-b72fedd6a581
• NDC: 53808-1130
• Product Type: Human Prescription Drug
• Proprietary Name: Tivicay
• Generic Name: Dolutegravir Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-10
• Marketing Category: NDA / NDA
• Application Number: NDA204790
• Labeler Name: DOH CENTRAL PHARMACY
• 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: 2020-12-31

Packaging

NDC 53808-1130-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1130-1)

• Marketing Start Date: 2017-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-1130-1 [53808113001]

Tivicay TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204790
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-10

Drug Details

Active Ingredients

Ingredient	Strength
DOLUTEGRAVIR SODIUM	50 mg/1

OpenFDA Data

• SPL SET ID: 807b0cd2-093c-4353-a4a5-2e1f264616ba
• Manufacturer:
  • DOH CENTRAL PHARMACY
• UNII:
  • 1Q1V9V5WYQ
• RxNorm Concept Unique ID - RxCUI:
  • 1433879
  • 1433873
• UPC Code:
  • 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]
• 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