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United States · US · US:42385-953_bf69c830-aa6f-4813-8421-6b3bd689086d

Emtricitabine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4238595330
    30 TABLET, FILM COATED in 1 BOTTLE (42385-953-30)
  • ndc11
    4238595390
    90 TABLET, FILM COATED in 1 BOTTLE (42385-953-90)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A212114
AB
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": "42385-953_bf69c830-aa6f-4813-8421-6b3bd689086d",
  "productndc": "42385-953",
  "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

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