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United States · US · US:43353-317_815744b6-6096-4a89-8171-cdca95e10631
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143353317099000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09)
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A090596
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": "43353-317_815744b6-6096-4a89-8171-cdca95e10631",
"productndc": "43353-317",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090596",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Sep 17, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Sep 17, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "003",
"approval_date": "Sep 17, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090596",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20151118",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L04AD02.
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