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United States · US · US:16729-041_3622f4f5-48bd-9035-e063-6294a90afac2
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 · 1
- ndc111672904101100 CAPSULE in 1 BOTTLE (16729-041-01)
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A091195
BXBXBX
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": "16729-041_3622f4f5-48bd-9035-e063-6294a90afac2",
"productndc": "16729-041",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "091195",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Aug 31, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Aug 31, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "EQ 5MG BASE",
"product_no": "003",
"approval_date": "Aug 31, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091195",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20110930",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code L04AD02.
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