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United States · US · US:61958-0601_13ed3577-67a4-4828-b886-f35206f149a6

Emtriva

Orange BookUNIISPLATC J05AF09

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AF09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195806011
    30 CAPSULE in 1 BOTTLE, PLASTIC (61958-0601-1)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N021500
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": {
    "d6599395-3944-44f9-97f2-e0424c6b6a1f": {
      "match": "brand_token",
      "title": "EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]",
      "spl_version": "13",
      "published_date": "2025-12-22"
    }
  },
  "productid": "61958-0601_13ed3577-67a4-4828-b886-f35206f149a6",
  "productndc": "61958-0601",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021500",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jul 2, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE",
  "proprietary_name": "Emtriva",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021500",
  "marketing_category": "NDA",
  "nonproprietary_name": "EMTRICITABINE",
  "start_marketing_date": "20030702",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J05AF09.

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