tacrolimus

Generic: tacrolimus ointment 0.1%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus ointment 0.1%
Labeler encube ethicals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

tacrolimus 1 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-011
Product ID 21922-011_9197a805-bb44-44b8-9ae7-d39a01acb1a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212387
Listing Expiration 2026-12-31
Marketing Start 2023-10-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922011
Hyphenated Format 21922-011

Supplemental Identifiers

RxCUI
314266
UPC
0321922011098 0321922011050 0321922011074
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 ointment 0.1% (source: ndc)
Application Number ANDA212387 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-011-09) / 100 g in 1 TUBE
source: ndc

Packages (3)

21922-011-05 1 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE 21922-011-07 1 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE 21922-011-09 1 TUBE in 1 CARTON (21922-011-09) / 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": "9197a805-bb44-44b8-9ae7-d39a01acb1a7", "openfda": {"upc": ["0321922011098", "0321922011050", "0321922011074"], "unii": ["WM0HAQ4WNM"], "rxcui": ["314266"], "spl_set_id": ["43b38551-6c5e-48a4-a453-9286f1c16b34"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-011-05)  / 30 g in 1 TUBE", "package_ndc": "21922-011-05", "marketing_start_date": "20231013"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-011-07)  / 60 g in 1 TUBE", "package_ndc": "21922-011-07", "marketing_start_date": "20231013"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-011-09)  / 100 g in 1 TUBE", "package_ndc": "21922-011-09", "marketing_start_date": "20231013"}], "brand_name": "Tacrolimus", "product_id": "21922-011_9197a805-bb44-44b8-9ae7-d39a01acb1a7", "dosage_form": "OINTMENT", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "21922-011", "generic_name": "Tacrolimus Ointment 0.1%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/g"}], "application_number": "ANDA212387", "marketing_category": "ANDA", "marketing_start_date": "20231013", "listing_expiration_date": "20261231"}