NDC 69238-1527

Emtricitabine and Tenofovir Disoproxil Fumarate

Emtricitabine And Tenofovir Disoproxil Fumarate

Emtricitabine and Tenofovir Disoproxil Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Emtricitabine; Tenofovir Disoproxil Fumarate.

• Product ID: 69238-1527_06c87805-1140-4900-8bd2-366aea76e4cb
• NDC: 69238-1527
• Product Type: Human Prescription Drug
• Proprietary Name: Emtricitabine and Tenofovir Disoproxil Fumarate
• Generic Name: Emtricitabine And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209721
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: EMTRICITABINE; TENOFOVIR DISOPROXIL 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: 2019-12-31

Packaging

NDC 69238-1527-3

30 TABLET, FILM COATED in 1 BOTTLE (69238-1527-3)

• Marketing Start Date: 2018-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69238-1527-3 [69238152703]

Emtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209721
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-26

Drug Details

Active Ingredients

Ingredient	Strength
EMTRICITABINE	200 mg/1

OpenFDA Data

• SPL SET ID: 70b3deb4-951d-4d9b-a811-be5fa05529a9
• Manufacturer:
  • Amneal Pharmaceuticals LLC
• UNII:
  • OTT9J7900I
  • G70B4ETF4S
• RxNorm Concept Unique ID - RxCUI:
  • 1744001
  • 1744009
  • 1744005
  • 476556
• UPC Code:
  • 0369238154832
  • 0369238154733
  • 0369238152739
  • 0369238154931

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 "Emtricitabine and Tenofovir Disoproxil Fumarate" or generic name "Emtricitabine And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
0093-7607	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
0093-7704	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
0378-1930	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
0904-7172	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
16714-534	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate
31722-560	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate
33342-106	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate
42291-439	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
42385-913	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
42385-953	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
42543-719	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate
50090-5957	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
51407-112	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate
60219-2092	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
60219-2093	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
60219-2094	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
60219-2095	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
60505-4202	Emtricitabine and Tenofovir Disoproxil Fumarate	emtricitabine and tenofovir disoproxil fumarate
69238-1547	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
69238-1527	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
69238-1548	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
69238-1549	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
69238-2094	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
69238-2095	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
69238-2092	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
72189-156	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
69238-2093	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate
35356-070	Truvada	emtricitabine and tenofovir disoproxil fumarate
50090-0870	Truvada	emtricitabine and tenofovir disoproxil fumarate
52959-969	Truvada	emtricitabine and tenofovir disoproxil fumarate
53808-0805	Truvada	emtricitabine and tenofovir disoproxil fumarate
61919-669	TRUVADA	emtricitabine and tenofovir disoproxil fumarate
61958-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate