🇺🇸
United States · US · US:0168-0417_a63cc4f4-5aba-4e02-915a-5535f2b625aa
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1101680417301 TUBE in 1 CARTON (0168-0417-30) / 30 g in 1 TUBE
- ndc1101680417601 TUBE in 1 CARTON (0168-0417-60) / 60 g in 1 TUBE
- ndc1101680417991 TUBE in 1 CARTON (0168-0417-99) / 100 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A200744
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": "0168-0417_a63cc4f4-5aba-4e02-915a-5535f2b625aa",
"productndc": "0168-0417",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "200744",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03%",
"product_no": "001",
"approval_date": "Sep 9, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "002",
"approval_date": "Sep 9, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/g",
"application_number": "ANDA200744",
"marketing_category": "ANDA",
"nonproprietary_name": "tacrolimus",
"start_marketing_date": "20140909",
"active_numerator_strength": ".3"
}Related drugs
Other records sharing ATC code L04AD02.
Access this data programmatically
Query Tacrolimus and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.