NDC 70518-0677

COMPLERA

Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate

COMPLERA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate.

• Product ID: 70518-0677_574bd82c-565e-516d-e053-2a91aa0af4f6
• NDC: 70518-0677
• Product Type: Human Prescription Drug
• Proprietary Name: COMPLERA
• Generic Name: Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-16
• Marketing Category: NDA / NDA
• Application Number: NDA202123
• Labeler Name: REMEDYREPACK INC.
• Substance Name: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL 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 70518-0677-1

30 POUCH in 1 BOX (70518-0677-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-0677-2)

• Marketing Start Date: 2021-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0677-0 [70518067700]

COMPLERA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202123
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Marketing End Date: 2020-05-01

Drug Details

Active Ingredients

Ingredient	Strength
EMTRICITABINE	200 mg/1

OpenFDA Data

• SPL SET ID: 28f49746-2d97-4f7c-a491-1775e5d17103
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • OTT9J7900I
  • 212WAX8KDD
  • G70B4ETF4S
• RxNorm Concept Unique ID - RxCUI:
  • 1147337
  • 1147334

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 "COMPLERA" or generic name "Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
50090-1248	COMPLERA	emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
61958-1101	COMPLERA	emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
70518-0677	COMPLERA	emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate