NDC 70518-0695

ODEFSEY

Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide

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

• Product ID: 70518-0695_575e629d-c8d8-1a63-e053-2991aa0ae40b
• NDC: 70518-0695
• Product Type: Human Prescription Drug
• Proprietary Name: ODEFSEY
• Generic Name: Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-17
• Marketing Category: NDA / NDA
• Application Number: NDA208351
• Labeler Name: REMEDYREPACK INC.
• Substance Name: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
• Active Ingredient Strength: 200 mg/1; mg/1; mg/1
• Pharm Classes: Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70518-0695-0

30 TABLET in 1 BLISTER PACK (70518-0695-0)

• Marketing Start Date: 2017-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0695-0 [70518069500]

ODEFSEY TABLET

• Marketing Category: NDA
• Application Number: NDA208351
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-17
• Marketing End Date: 2020-05-01

Drug Details

Active Ingredients

Ingredient	Strength
EMTRICITABINE	200 mg/1

OpenFDA Data

• SPL SET ID: 0f7e4fbb-b6a8-4be9-81a4-c92e288a33d9
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 212WAX8KDD
  • G70B4ETF4S
  • FWF6Q91TZO
• RxNorm Concept Unique ID - RxCUI:
  • 1741733
  • 1741739

Pharmacological Class

• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Non-Nucleoside Analog [EXT]
• 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 "ODEFSEY" or generic name "Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide"

NDC	Brand Name	Generic Name
50090-2340	ODEFSEY	emtricitabine, rilpivirine, and tenofovir alafenamide
61958-2101	ODEFSEY	emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
70518-0695	ODEFSEY	emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide