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United States · US · US:68992-3040_163c129d-f4e2-484d-af96-c265c9a5e38c
Envarsus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVeloxis Pharmaceuticals, Inc
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168992304011 POUCH in 1 CARTON (68992-3040-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1168992304031 POUCH in 1 CARTON (68992-3040-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
N206406
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": {
"de2315b0-6344-43ac-9aea-3e3b68d828e7": {
"match": "brand_token",
"title": "ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]",
"spl_version": "16",
"published_date": "2025-03-03"
}
},
"productid": "68992-3040_163c129d-f4e2-484d-af96-c265c9a5e38c",
"productndc": "68992-3040",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206406",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.75MG BASE",
"product_no": "001",
"approval_date": "Jul 10, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Jul 10, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "003",
"approval_date": "Jul 10, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Envarsus",
"active_ingred_unit": "mg/1",
"application_number": "NDA206406",
"marketing_category": "NDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20150901",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code L04AD02.
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