EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

G70B4ETF4S

EMTRICITABINE

RxCUI 276237

Orange Book

A204131

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "G70B4ETF4S",
    "rxcui": "276237",
    "inchikey": "XQSPYNMVSIKCOC-NTSWFWBYSA-N",
    "display_name": "EMTRICITABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4feb83a5-9142-0c67-e063-6394a90a710f": {
      "match": "brand_token",
      "title": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-22"
    }
  },
  "productid": "68180-287_1b7981ee-8124-46a2-9aab-f9b85d982650",
  "productndc": "68180-287",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204131",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Jun 4, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA204131",
  "marketing_category": "ANDA",
  "nonproprietary_name": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE",
  "start_marketing_date": "20210623",
  "active_numerator_strength": "200; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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