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United States · US · US:55111-526_706bafff-d629-291c-5ce5-83d74a638860
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1155111526011 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE
- ndc1155111526051 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE
- ndc1155111526301 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE
- ndc11551115267810 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79)
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A090509
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": "55111-526_706bafff-d629-291c-5ce5-83d74a638860",
"productndc": "55111-526",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090509",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "May 12, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "May 12, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "003",
"approval_date": "May 12, 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": "ANDA090509",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20100514",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L04AD02.
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