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United States · US · US:0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5

Crotan

Orange BookUNIISPL

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

Identification

ManufacturerMarnel Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0682005110
    237 g in 1 BOTTLE, PLASTIC (0682-0051-10)
  • ndc11
    0682005120
    60 g in 1 BOTTLE, PLASTIC (0682-0051-20)
  • ndc11
    0682005130
    454 g in 1 BOTTLE, PLASTIC (0682-0051-30)

Annotations

UNII (FDA Substance ID)
D6S4O4XD0H
CROTAMITON
RxCUI 21766
Orange Book
A087204
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "D6S4O4XD0H",
    "rxcui": "21766",
    "inchikey": null,
    "display_name": "CROTAMITON",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "6f7478fa-ed2b-4943-9d40-1fd0161a0854": {
      "match": "brand_token",
      "title": "CROTAN (CROTAMITON) LOTION [MARNEL PHARMACEUTICALS, INC.]",
      "spl_version": "11",
      "published_date": "2024-04-22"
    }
  },
  "productid": "0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5",
  "productndc": "0682-0051",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "087204",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CROTAMITON",
  "proprietary_name": "Crotan",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA087204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Crotamiton",
  "start_marketing_date": "20220115",
  "active_numerator_strength": "100"
}

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