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United States · US · US:42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8

Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF07

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeJ05AF07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229180030
    30 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)

Annotations

UNII (FDA Substance ID)
OTT9J7900I
TENOFOVIR DISOPROXIL FUMARATE
RxCUI 322248
Orange Book
A090636
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "OTT9J7900I",
    "rxcui": "322248",
    "inchikey": "VCMJCVGFSROFHV-WZGZYPNHSA-N",
    "display_name": "TENOFOVIR DISOPROXIL FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7f0bc342-0a0a-1d28-e053-2991aa0a28b9": {
      "match": "brand_token",
      "title": "TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AVKARE]",
      "spl_version": "5",
      "published_date": "2026-01-16"
    }
  },
  "productid": "42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8",
  "productndc": "42291-800",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090636",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Jan 26, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Tenofovir Disoproxil Fumarate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090636",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20190110",
  "active_numerator_strength": "300"
}

Related drugs

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