🇺🇸
United States · US · US:0469-3016_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
- ndc11046930160110 AMPULE in 1 BOX (0469-3016-01) / 1 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
N050709
AP
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": "INTRAVENOUS",
"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": "0469-3016_e9157663-1515-4ba3-83b5-1622cf6f0f99",
"productndc": "0469-3016",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "050709",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 8, 1994"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Prograf",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050709",
"marketing_category": "NDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "19940408",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L04AD02.
Access this data programmatically
Query Prograf and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.