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United States · US · US:49348-379_3a76faa8-aa42-362d-e063-6294a90a2eab

sunmark

Orange BookUNIISPLATC A01AB18

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

Identification

ManufacturerStrategic Sourcing Services LLC
CountryUS (United States)
ATC codeA01AB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4934837954
    1 TUBE, WITH APPLICATOR in 1 CARTON (49348-379-54) / 21 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
N021143
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G07GZ97H65",
    "rxcui": "2623",
    "inchikey": "VNFPBHJOKIVQEB-UHFFFAOYSA-N",
    "display_name": "CLOTRIMAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "06720229-7d58-499e-b7de-cb4bda5ae416": {
      "match": "brand_token",
      "title": "SUNMARK SALINE SINGLE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [STRATEGIC SOURCING SERVICES LLC]",
      "spl_version": "5",
      "published_date": "2026-01-12"
    }
  },
  "productid": "49348-379_3a76faa8-aa42-362d-e063-6294a90a2eab",
  "productndc": "49348-379",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "021143",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Apr 12, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CLOTRIMAZOLE",
  "proprietary_name": "sunmark",
  "active_ingred_unit": "g/100g",
  "application_number": "NDA021143",
  "marketing_category": "NDA",
  "nonproprietary_name": "Clotrimazole",
  "start_marketing_date": "20000412",
  "active_numerator_strength": "2"
}

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