Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeJ05AF07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6586281903
3 BLISTER PACK in 1 CARTON (65862-819-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6586281930
30 TABLET, FILM COATED in 1 BOTTLE (65862-819-30)

Annotations

UNII (FDA Substance ID)

OTT9J7900I

TENOFOVIR DISOPROXIL FUMARATE

RxCUI 322248

Orange Book

A090647

ABABABAB

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": "65862-819_ab772f55-3f84-41df-a84f-3a7035602cfd",
  "productndc": "65862-819",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090647",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jan 26, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jan 26, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "Jan 26, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "004",
        "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": "ANDA090647",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20180126",
  "active_numerator_strength": "200"
}

Related drugs

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