NDC 70518-0230

DESCOVY

Emtricitabine And Tenofovir Alafenamide Fumarate

DESCOVY is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Emtricitabine; Tenofovir Alafenamide Fumarate.

• Product ID: 70518-0230_8312635b-e182-4447-e053-2a91aa0a4b04
• NDC: 70518-0230
• Product Type: Human Prescription Drug
• Proprietary Name: DESCOVY
• Generic Name: Emtricitabine And Tenofovir Alafenamide Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-16
• Marketing Category: NDA / NDA
• Application Number: NDA208215
• Labeler Name: REMEDYREPACK INC.
• Substance Name: EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
• Active Ingredient Strength: 200 mg/1; mg/1
• Pharm Classes: Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-0230-0

30 TABLET in 1 BLISTER PACK (70518-0230-0)

• Marketing Start Date: 2017-02-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0230-0 [70518023000]

DESCOVY TABLET

• Marketing Category: NDA
• Application Number: NDA208215
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-16

Drug Details

Active Ingredients

Ingredient	Strength
EMTRICITABINE	200 mg/1

OpenFDA Data

• SPL SET ID: eccee400-e198-4071-92a8-39c51948f699
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • G70B4ETF4S
  • FWF6Q91TZO
• RxNorm Concept Unique ID - RxCUI:
  • 1747697
  • 1747691

Pharmacological Class

• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]

NDC Crossover Matching brand name "DESCOVY" or generic name "Emtricitabine And Tenofovir Alafenamide Fumarate"

NDC	Brand Name	Generic Name
61958-2002	DESCOVY	emtricitabine and tenofovir alafenamide
61958-2005	DESCOVY	emtricitabine and tenofovir alafenamide
70518-0230	DESCOVY	emtricitabine and tenofovir alafenamide fumarate