tacrolimus

Generic: tacrolimus

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

tacrolimus 1 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0416
Product ID 0168-0416_a63cc4f4-5aba-4e02-915a-5535f2b625aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200744
Listing Expiration 2027-12-31
Marketing Start 2014-09-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680416
Hyphenated Format 0168-0416

Supplemental Identifiers

RxCUI
313189 314266
UPC
0301680417608 0301680416601
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 ANDA200744 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0168-0416-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0416-60) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0416-99) / 100 g in 1 TUBE
source: ndc

Packages (3)

0168-0416-30 1 TUBE in 1 CARTON (0168-0416-30) / 30 g in 1 TUBE 0168-0416-60 1 TUBE in 1 CARTON (0168-0416-60) / 60 g in 1 TUBE 0168-0416-99 1 TUBE in 1 CARTON (0168-0416-99) / 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": "a63cc4f4-5aba-4e02-915a-5535f2b625aa", "openfda": {"upc": ["0301680417608", "0301680416601"], "unii": ["WM0HAQ4WNM"], "rxcui": ["313189", "314266"], "spl_set_id": ["1bf44a84-14fd-4f80-ad8a-99b1431d631f"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0416-30)  / 30 g in 1 TUBE", "package_ndc": "0168-0416-30", "marketing_start_date": "20140909"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0416-60)  / 60 g in 1 TUBE", "package_ndc": "0168-0416-60", "marketing_start_date": "20140909"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0416-99)  / 100 g in 1 TUBE", "package_ndc": "0168-0416-99", "marketing_start_date": "20140909"}], "brand_name": "Tacrolimus", "product_id": "0168-0416_a63cc4f4-5aba-4e02-915a-5535f2b625aa", "dosage_form": "OINTMENT", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0168-0416", "generic_name": "tacrolimus", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/g"}], "application_number": "ANDA200744", "marketing_category": "ANDA", "marketing_start_date": "20140909", "listing_expiration_date": "20271231"}