NDC 72606-002

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 Usa, Inc.. The primary component is Lamivudine; Tenofovir Disoproxil Fumarate.

• Product ID: 72606-002_0732cedf-911f-4b66-b610-3790d1df6b9e
• NDC: 72606-002
• 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 USA, 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 72606-002-01

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72606-002-01)

• Marketing Start Date: 2019-11-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72606-002-01 [72606000201]

TEMIXYS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211284
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-11-07

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	300 mg/1

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