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United States · US · US:16729-421_23a804e6-2854-6b9b-e063-6394a90af669
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1116729421011 TUBE in 1 CARTON (16729-421-01) / 100 g in 1 TUBE
- ndc1116729421101 TUBE in 1 CARTON (16729-421-10) / 30 g in 1 TUBE
- ndc1116729421121 TUBE in 1 CARTON (16729-421-12) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A211688
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": "16729-421_23a804e6-2854-6b9b-e063-6394a90af669",
"productndc": "16729-421",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "211688",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03%",
"product_no": "001",
"approval_date": "Jan 31, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "002",
"approval_date": "Jan 31, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/g",
"application_number": "ANDA211688",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20190531",
"active_numerator_strength": ".3"
}Related drugs
Other records sharing ATC code L04AD02.
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