adefovir dipivoxil

Generic: adefovir dipivoxil

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adefovir dipivoxil
Generic Name adefovir dipivoxil
Labeler sigmapharm laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

adefovir dipivoxil 10 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-003
Product ID 42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202051
Listing Expiration 2026-12-31
Marketing Start 2013-09-03

Pharmacologic Class

Classes
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] nucleoside analog [ext] nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794003
Hyphenated Format 42794-003

Supplemental Identifiers

RxCUI
881341
UPC
0342794003080
UNII
U6Q8Z01514

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name adefovir dipivoxil (source: ndc)
Generic Name adefovir dipivoxil (source: ndc)
Application Number ANDA202051 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42794-003-08) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (1)

adefovir dipivoxil (10 mg/1)

Linked Drug Pages (1)

ADEFOVIR DIPIVOXIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f7ac2b46-04c8-a739-e053-6394a90a7711", "openfda": {"upc": ["0342794003080"], "unii": ["U6Q8Z01514"], "rxcui": ["881341"], "spl_set_id": ["e047f3b2-feae-4c5e-9d07-1fefb4c0ec25"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42794-003-08)  / 30 TABLET in 1 BOTTLE", "package_ndc": "42794-003-08", "marketing_start_date": "20160718"}], "brand_name": "ADEFOVIR DIPIVOXIL", "product_id": "42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "42794-003", "generic_name": "ADEFOVIR DIPIVOXIL", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ADEFOVIR DIPIVOXIL", "active_ingredients": [{"name": "ADEFOVIR DIPIVOXIL", "strength": "10 mg/1"}], "application_number": "ANDA202051", "marketing_category": "ANDA", "marketing_start_date": "20130903", "listing_expiration_date": "20261231"}