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United States · US · US:45802-390_ca08f41f-bc87-45bb-91b8-1d89adfba78f

Tacrolimus

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeL04AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4580239000
    1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE
  • ndc11
    4580239001
    1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE
  • ndc11
    4580239002
    1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
N050777
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WM0HAQ4WNM",
    "rxcui": "484288",
    "inchikey": "NWJQLQGQZSIBAF-MLAUYUEBSA-N",
    "display_name": "TACROLIMUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f": {
      "match": "brand_token",
      "title": "TACROLIMUS (TACROLIMUS) CAPSULE [BIOCON PHARMA INC.]",
      "spl_version": "12",
      "published_date": "2026-05-26"
    }
  },
  "productid": "45802-390_ca08f41f-bc87-45bb-91b8-1d89adfba78f",
  "productndc": "45802-390",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "050777",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.03%",
        "product_no": "001",
        "approval_date": "Dec 8, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "002",
        "approval_date": "Dec 8, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "Tacrolimus",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA050777",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tacrolimus",
  "start_marketing_date": "20141120",
  "active_numerator_strength": ".3"
}

Related drugs

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