NDC 32228-004

TEMIXYS

Lamivudine And Tenofovir Disoproxil Fumarate

TEMIXYS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Celltrion, Inc.. The primary component is Lamivudine; Tenofovir Disoproxil Fumarate.

• Product ID: 32228-004_9e1f1f00-f7b5-4beb-b4ef-2fe85a5dfdbb
• NDC: 32228-004
• Product Type: Human Prescription Drug
• Proprietary Name: TEMIXYS
• Generic Name: Lamivudine And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-16
• Marketing Category: NDA / NDA
• Application Number: NDA211284
• Labeler Name: CELLTRION, INC.
• Substance Name: LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
• Active Ingredient Strength: 300 mg/1; mg/1
• Pharm Classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],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 32228-004-01

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (32228-004-01)

• Marketing Start Date: 2019-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 32228-004-01 [32228000401]

TEMIXYS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211284
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-30
• Marketing End Date: 2019-09-09

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	300 mg/1

OpenFDA Data

• SPL SET ID: b069bc8e-db09-4d2c-b8b6-5438db4a24a2
• Manufacturer:
  • CELLTRION, INC.
• UNII:
  • OTT9J7900I
  • 2T8Q726O95

Pharmacological Class

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

NDC Crossover Matching brand name "TEMIXYS" or generic name "Lamivudine And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
32228-004	TEMIXYS	lamivudine and tenofovir disoproxil fumarate
72606-002	TEMIXYS	lamivudine and tenofovir disoproxil fumarate
49502-450	CIMDUO	Lamivudine and Tenofovir Disoproxil Fumarate