envarsus xr

Generic: tacrolimus

Labeler: veloxis pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name envarsus xr
Generic Name tacrolimus
Labeler veloxis pharmaceuticals, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tacrolimus .75 mg/1

Manufacturer
Veloxis Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 68992-3075
Product ID 68992-3075_163c129d-f4e2-484d-af96-c265c9a5e38c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206406
Listing Expiration 2026-12-31
Marketing Start 2015-09-01

Pharmacologic Class

Classes
calcineurin inhibitor immunosuppressant [epc] calcineurin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 689923075
Hyphenated Format 68992-3075

Supplemental Identifiers

RxCUI
1664434 1664440 1664456 1664458 1664461 1664463
UPC
0368992304033 0368992301032 0368992307539 0368992301018 0368992307515
UNII
WM0HAQ4WNM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name envarsus xr (source: ndc)
Generic Name tacrolimus (source: ndc)
Application Number NDA206406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (68992-3075-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 POUCH in 1 CARTON (68992-3075-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

68992-3075-1 1 POUCH in 1 CARTON (68992-3075-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 68992-3075-3 1 POUCH in 1 CARTON (68992-3075-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Ingredients (1)

tacrolimus (.75 mg/1)

Linked Drug Pages (1)

Envarsus XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "163c129d-f4e2-484d-af96-c265c9a5e38c", "openfda": {"upc": ["0368992304033", "0368992301032", "0368992307539", "0368992301018", "0368992307515"], "unii": ["WM0HAQ4WNM"], "rxcui": ["1664434", "1664440", "1664456", "1664458", "1664461", "1664463"], "spl_set_id": ["de2315b0-6344-43ac-9aea-3e3b68d828e7"], "manufacturer_name": ["Veloxis Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (68992-3075-1)  / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "68992-3075-1", "marketing_start_date": "20150901"}, {"sample": false, "description": "1 POUCH in 1 CARTON (68992-3075-3)  / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "68992-3075-3", "marketing_start_date": "20150901"}], "brand_name": "Envarsus XR", "product_id": "68992-3075_163c129d-f4e2-484d-af96-c265c9a5e38c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68992-3075", "generic_name": "Tacrolimus", "labeler_name": "Veloxis Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Envarsus", "brand_name_suffix": "XR", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".75 mg/1"}], "application_number": "NDA206406", "marketing_category": "NDA", "marketing_start_date": "20150901", "listing_expiration_date": "20261231"}