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United States · US · US:42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711

ADEFOVIR DIPIVOXIL

In shortageOrange BookUNIISPLATC J05AF08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSigmapharm Laboratories, LLC
CountryUS (United States)
ATC codeJ05AF08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4279400308
    1 BOTTLE in 1 CARTON (42794-003-08) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
U6Q8Z01514
ADEFOVIR DIPIVOXIL
RxCUI 141400
Orange Book
A202051
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Adefovir Dipivoxil Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "U6Q8Z01514",
    "rxcui": "141400",
    "inchikey": "WOZSCQDILHKSGG-UHFFFAOYSA-N",
    "display_name": "ADEFOVIR DIPIVOXIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "08e07fae-3191-b6a3-c894-d3a8cc53923f": {
      "match": "brand_token",
      "title": "ADEFOVIR DIPIVOXIL TABLET [APOTEX CORP.]",
      "spl_version": "8",
      "published_date": "2025-07-24"
    }
  },
  "productid": "42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711",
  "productndc": "42794-003",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202051",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ADEFOVIR DIPIVOXIL",
  "shortage_reason": "Adefovir Dipivoxil Tablet",
  "shortage_status": "current",
  "proprietary_name": "ADEFOVIR DIPIVOXIL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202051",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ADEFOVIR DIPIVOXIL",
  "start_marketing_date": "20130903",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code J05AF08.

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