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United States · US · US:65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6

Emtricitabine

Orange BookUNIISPLATC J05AF09

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AF09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6586230105
    500 CAPSULE in 1 BOTTLE (65862-301-05)
  • ndc11
    6586230130
    30 CAPSULE in 1 BOTTLE (65862-301-30)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A079188
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": "65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6",
  "productndc": "65862-301",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "079188",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Mar 15, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE",
  "proprietary_name": "Emtricitabine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079188",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine",
  "start_marketing_date": "20230315",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J05AF09.

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