NDC 42794-003

ADEFOVIR DIPIVOXIL

Adefovir Dipivoxil

ADEFOVIR DIPIVOXIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Adefovir Dipivoxil.

• Product ID: 42794-003_72cbabf0-4d8a-37e1-e053-2a91aa0ab9aa
• NDC: 42794-003
• Product Type: Human Prescription Drug
• Proprietary Name: ADEFOVIR DIPIVOXIL
• Generic Name: Adefovir Dipivoxil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-09-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202051
• Labeler Name: Sigmapharm Laboratories, LLC
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42794-003-08

1 BOTTLE in 1 CARTON (42794-003-08) > 30 TABLET in 1 BOTTLE

• Marketing Start Date: 2016-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42794-003-08 [42794000308]

ADEFOVIR DIPIVOXIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA202051
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-18

Drug Details

Active Ingredients

Ingredient	Strength
ADEFOVIR DIPIVOXIL	10 mg/1

OpenFDA Data

• SPL SET ID: e047f3b2-feae-4c5e-9d07-1fefb4c0ec25
• Manufacturer:
  • Sigmapharm Laboratories, LLC
• UNII:
  • U6Q8Z01514
• RxNorm Concept Unique ID - RxCUI:
  • 881341
• UPC Code:
  • 0342794003080

Pharmacological Class

• Hepatitis B 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]

Medicade Reported Pricing

42794000308 ADEFOVIR DIPIVOXIL 10 MG TAB

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "ADEFOVIR DIPIVOXIL" or generic name "Adefovir Dipivoxil"

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