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United States · US · US:68682-111_e391204d-95f9-4c57-a0db-578bdd1b8bde

Pimecrolimus

Orange BookUNIISPLATC D11AH02

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

Identification

ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeD11AH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6868211102
    1 TUBE in 1 CARTON (68682-111-02) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
7KYV510875
PIMECROLIMUS
RxCUI 321952
Orange Book
N021302
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7KYV510875",
    "rxcui": "321952",
    "inchikey": "KASDHRXLYQOAKZ-XDSKOBMDSA-N",
    "display_name": "PIMECROLIMUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "6601e43e-ce7d-446a-8568-8e7b24b86f06": {
      "match": "brand_token",
      "title": "PIMECROLIMUS CREAM [OCEANSIDE PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "68682-111_e391204d-95f9-4c57-a0db-578bdd1b8bde",
  "productndc": "68682-111",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "021302",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Dec 13, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIMECROLIMUS",
  "proprietary_name": "Pimecrolimus",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA021302",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Pimecrolimus",
  "start_marketing_date": "20181126",
  "active_numerator_strength": "10"
}

Related drugs

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