NDC 53808-0208

Atripla

Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate

Atripla 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 Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate.

• Product ID: 53808-0208_20fe8a0b-95db-4d4c-80e2-54a9126ab845
• NDC: 53808-0208
• Product Type: Human Prescription Drug
• Proprietary Name: Atripla
• Generic Name: Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021937
• Labeler Name: DOH CENTRAL PHARMACY
• Substance Name: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
• Active Ingredient Strength: 600 mg/1; mg/1; mg/1
• Pharm Classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],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: 2019-12-31

Packaging

NDC 53808-0208-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0208-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0208-1 [53808020801]

Atripla TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021937
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	600 mg/1

OpenFDA Data

• SPL SET ID: 076da359-b3d0-44f7-8c0e-662f5b7a8668
• Manufacturer:
  • DOH CENTRAL PHARMACY
• UNII:
  • OTT9J7900I
  • JE6H2O27P8
  • G70B4ETF4S
• RxNorm Concept Unique ID - RxCUI:
  • 643070
  • 643066
• UPC Code:
  • 0315584010117

Pharmacological Class

• Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Non-Nucleoside Analog [EXT]
• Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Cytochrome P450 3A Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• 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 "Atripla" or generic name "Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
15584-0101	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate
50090-0980	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate
53808-0208	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate