NDC 49502-450

CIMDUO

Lamivudine And Tenofovir Disoproxil Fumarate

CIMDUO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Lamivudine; Tenofovir Disoproxil Fumarate.

• Product ID: 49502-450_6e54ea13-a4be-4744-b1d6-e444181c0741
• NDC: 49502-450
• Product Type: Human Prescription Drug
• Proprietary Name: CIMDUO
• Generic Name: Lamivudine And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-25
• Marketing Category: NDA / NDA
• Application Number: NDA022141
• Labeler Name: Mylan Specialty L.P.
• 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 49502-450-93

1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2018-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49502-450-93 [49502045093]

CIMDUO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022141
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-25

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	300 mg/1

OpenFDA Data

• SPL SET ID: a300f04d-118f-4136-aaf3-ddfd00197f86
• Manufacturer:
  • Mylan Specialty L.P.
• UNII:
  • OTT9J7900I
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 2003255
  • 2003249

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]
• 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]
• 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 Crossover Matching brand name "CIMDUO" or generic name "Lamivudine And Tenofovir Disoproxil Fumarate"

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