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United States · US · US:69751-400_4a3aa8e8-bb23-46ce-998d-69dc7c9fb386

Solosec

Orange BookUNIISPLATC P01AB07

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

Identification

ManufacturerEvofem Inc.
CountryUS (United States)
ATC codeP01AB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6975140001
    1 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKET

Annotations

UNII (FDA Substance ID)
R3459K699K
SECNIDAZOLE
RxCUI 36314
Orange Book
N209363
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R3459K699K",
    "rxcui": "36314",
    "inchikey": "KPQZUUQMTUIKBP-UHFFFAOYSA-N",
    "display_name": "SECNIDAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "056485b6-8bba-4a21-ae00-cdb4e7ae4bfa": {
      "match": "brand_token",
      "title": "SOLOSEC (SECNIDAZOLE) GRANULE [EVOFEM INC.]",
      "spl_version": "1",
      "published_date": "2025-02-24"
    }
  },
  "productid": "69751-400_4a3aa8e8-bb23-46ce-998d-69dc7c9fb386",
  "productndc": "69751-400",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "209363",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2GM/PACKET",
        "product_no": "001",
        "approval_date": "Sep 15, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SECNIDAZOLE",
  "proprietary_name": "Solosec",
  "active_ingred_unit": "g/4.8g",
  "application_number": "NDA209363",
  "marketing_category": "NDA",
  "nonproprietary_name": "secnidazole",
  "start_marketing_date": "20180531",
  "active_numerator_strength": "2"
}

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