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United States · US · US:67877-279_46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116787727901100 CAPSULE in 1 BOTTLE (67877-279-01)
- ndc11678772793350 BLISTER PACK in 1 CARTON (67877-279-33) / 1 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A203740
ABABAB
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": "ORAL",
"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": "67877-279_46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac",
"productndc": "67877-279",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203740",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Nov 12, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Nov 12, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "003",
"approval_date": "Nov 12, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203740",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20201113",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L04AD02.
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