Emtricitabine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009064941
30 TABLET, FILM COATED in 1 BOTTLE (50090-6494-1)

Annotations

UNII (FDA Substance ID)

G70B4ETF4S

EMTRICITABINE

RxCUI 276237

Orange Book

A212114

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": "50090-6494_b74c0905-386e-43e9-b05a-cf6c7779ab77",
  "productndc": "50090-6494",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2019"
      }
    ],
    "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": "ANDA212114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20190726",
  "active_numerator_strength": "200; 300"
}

Related drugs

Other records sharing ATC code J05AF.

Access this data programmatically

Query Emtricitabine and Tenofovir Disoproxil Fumarate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs