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United States · US · US:0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b

SOOLANTRA

Orange BookUNIISPLATC D11AX22

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

Identification

ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeD11AX22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    0299382300
    2 g in 1 TUBE (0299-3823-00)
  • ndc11
    0299382302
    1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE
  • ndc11
    0299382330
    1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE
  • ndc11
    0299382345
    1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE
  • ndc11
    0299382360
    1 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
8883YP2R6D
IVERMECTIN
RxCUI 6069
Orange Book
N206255
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8883YP2R6D",
    "rxcui": "6069",
    "inchikey": null,
    "display_name": "IVERMECTIN",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "b1d5b166-ab06-4ab5-b0c6-31126238118a": {
      "match": "brand_token",
      "title": "SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]",
      "spl_version": "8",
      "published_date": "2024-10-28"
    }
  },
  "productid": "0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b",
  "productndc": "0299-3823",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "206255",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Dec 19, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVERMECTIN",
  "proprietary_name": "SOOLANTRA",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA206255",
  "marketing_category": "NDA",
  "nonproprietary_name": "IVERMECTIN",
  "start_marketing_date": "20150101",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code D11AX22.

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