tacrolimus

Generic: tacrolimus

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler padagis israel pharmaceuticals ltd
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

tacrolimus 1 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-700
Product ID 45802-700_ca08f41f-bc87-45bb-91b8-1d89adfba78f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050777
Listing Expiration 2026-12-31
Marketing Start 2014-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802700
Hyphenated Format 45802-700

Supplemental Identifiers

RxCUI
313189 314266
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 tacrolimus (source: ndc)
Generic Name tacrolimus (source: ndc)
Application Number NDA050777 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-700-00) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-700-01) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-700-02) / 100 g in 1 TUBE
source: ndc

Packages (3)

45802-700-00 1 TUBE in 1 CARTON (45802-700-00) / 30 g in 1 TUBE 45802-700-01 1 TUBE in 1 CARTON (45802-700-01) / 60 g in 1 TUBE 45802-700-02 1 TUBE in 1 CARTON (45802-700-02) / 100 g in 1 TUBE

Ingredients (1)

tacrolimus (1 mg/g)

Linked Drug Pages (1)

Tacrolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ca08f41f-bc87-45bb-91b8-1d89adfba78f", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["313189", "314266"], "spl_set_id": ["6b601eaf-4f3a-4a8b-8cd8-1000defa9822"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-700-00)  / 30 g in 1 TUBE", "package_ndc": "45802-700-00", "marketing_start_date": "20141120"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-700-01)  / 60 g in 1 TUBE", "package_ndc": "45802-700-01", "marketing_start_date": "20141120"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-700-02)  / 100 g in 1 TUBE", "package_ndc": "45802-700-02", "marketing_start_date": "20141120"}], "brand_name": "Tacrolimus", "product_id": "45802-700_ca08f41f-bc87-45bb-91b8-1d89adfba78f", "dosage_form": "OINTMENT", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "45802-700", "generic_name": "Tacrolimus", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/g"}], "application_number": "NDA050777", "marketing_category": "NDA", "marketing_start_date": "20141120", "listing_expiration_date": "20261231"}