NDC 0904-6821

tenofovir disproxil fumarate

Tenofovir Disproxil Fumarate

tenofovir disproxil fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Tenofovir Disoproxil Fumarate.

• Product ID: 0904-6821_da78a5d3-f5c6-47fe-b593-3252704c225d
• NDC: 0904-6821
• Product Type: Human Prescription Drug
• Proprietary Name: tenofovir disproxil fumarate
• Generic Name: Tenofovir Disproxil Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-01-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203232
• Labeler Name: Major Pharmaceuticals
• Substance Name: TENOFOVIR DISOPROXIL FUMARATE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: 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: 2020-12-31

Packaging

NDC 0904-6821-04

30 BLISTER PACK in 1 CARTON (0904-6821-04) > 1 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2018-01-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6821-04 [00904682104]

tenofovir disproxil fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA203232
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-01-26

Drug Details

Active Ingredients

Ingredient	Strength
TENOFOVIR DISOPROXIL FUMARATE	300 mg/1

OpenFDA Data

• SPL SET ID: da78a5d3-f5c6-47fe-b593-3252704c225d
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • OTT9J7900I
• RxNorm Concept Unique ID - RxCUI:
  • 349251

Pharmacological Class

• 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]
• 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 "tenofovir disproxil fumarate" or generic name "Tenofovir Disproxil Fumarate"

NDC	Brand Name	Generic Name
0904-6821	tenofovir disproxil fumarate	tenofovir disproxil fumarate
33342-096	tenofovir disproxil fumarate	tenofovir disproxil fumarate