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United States · US · US:0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43

pimecrolimus

Orange BookUNIISPLATC D11AH02

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeD11AH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0591294430
    30 g in 1 TUBE (0591-2944-30)
  • ndc11
    0591294460
    60 g in 1 TUBE (0591-2944-60)
  • ndc11
    0591294487
    100 g in 1 TUBE (0591-2944-87)

Annotations

UNII (FDA Substance ID)
7KYV510875
PIMECROLIMUS
RxCUI 321952
Orange Book
A209345
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": "0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43",
  "productndc": "0591-2944",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "209345",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Dec 27, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIMECROLIMUS",
  "proprietary_name": "pimecrolimus",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA209345",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pimecrolimus",
  "start_marketing_date": "20181227",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code D11AH02.

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