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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
- ndc1145802390001 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE
- ndc1145802390011 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE
- ndc1145802390021 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
Other records sharing ATC code L04AD02.
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