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United States · US · US:0469-0607_e9157663-1515-4ba3-83b5-1622cf6f0f99
Prograf
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104690607731 BOTTLE in 1 CARTON (0469-0607-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
N050708
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": {
"7f667de1-9dfa-4bd6-8ba0-15ee2d78873b": {
"match": "brand_token",
"title": "PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION PROGRAF (TACROLIMUS) GRANULE, FOR SUSPENSION [ASTELLAS PHARMA US, INC.]",
"spl_version": "30",
"published_date": "2025-03-21"
}
},
"productid": "0469-0607_e9157663-1515-4ba3-83b5-1622cf6f0f99",
"productndc": "0469-0607",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "050708",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Apr 8, 1994"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Apr 8, 1994"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "003",
"approval_date": "Aug 24, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Prograf",
"active_ingred_unit": "mg/1",
"application_number": "NDA050708",
"marketing_category": "NDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "19980824",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code L04AD02.
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