NDC 46014-0501

Hepsera

Adefovir Dipivoxil

Hepsera is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Excella Gmbh. The primary component is Adefovir Dipivoxil.

• Product ID: 46014-0501_8b66b3f1-06d1-4afa-8bfc-af6c19fcd649
• NDC: 46014-0501
• Product Type: Human Prescription Drug
• Proprietary Name: Hepsera
• Generic Name: Adefovir Dipivoxil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2002-09-20
• Marketing Category: NDA / NDA
• Application Number: NDA021449
• Labeler Name: Excella GmbH
• Substance Name: ADEFOVIR DIPIVOXIL
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 46014-0501-1

30 TABLET in 1 BOTTLE, PLASTIC (46014-0501-1)

• Marketing Start Date: 2002-09-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46014-0501-1 [46014050101]

Hepsera TABLET

• Marketing Category: NDA
• Application Number: NDA021449
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-09-20
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ADEFOVIR DIPIVOXIL	10 mg/1

OpenFDA Data

• SPL SET ID: 80595d45-2224-47d1-bd5c-4b11a824e5bd
• Manufacturer:
  • Excella GmbH
• UNII:
  • U6Q8Z01514
• RxNorm Concept Unique ID - RxCUI:
  • 881343
  • 881341

Pharmacological Class

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

NDC Crossover Matching brand name "Hepsera" or generic name "Adefovir Dipivoxil"

NDC	Brand Name	Generic Name
46014-0501	Hepsera	Adefovir Dipivoxil
61958-0501	Hepsera	adefovir dipivoxil
42794-003	ADEFOVIR DIPIVOXIL	ADEFOVIR DIPIVOXIL
60505-3947	Adefovir dipivoxil	adefovir dipivoxil