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United States · US · US:21922-011_9197a805-bb44-44b8-9ae7-d39a01acb1a7
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1121922011051 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE
- ndc1121922011071 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE
- ndc1121922011091 TUBE in 1 CARTON (21922-011-09) / 100 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A212387
BX
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": "21922-011_9197a805-bb44-44b8-9ae7-d39a01acb1a7",
"productndc": "21922-011",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "212387",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Oct 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/g",
"application_number": "ANDA212387",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus Ointment 0.1%",
"start_marketing_date": "20231013",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L04AD02.
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