tacrolimus

Generic: tacrolimus

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler accord healthcare inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

tacrolimus 1 mg/g

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-422
Product ID 16729-422_23a804e6-2854-6b9b-e063-6394a90af669
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211688
Listing Expiration 2026-12-31
Marketing Start 2019-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729422
Hyphenated Format 16729-422

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 ANDA211688 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (16729-422-01) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16729-422-10) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16729-422-12) / 60 g in 1 TUBE
source: ndc

Packages (3)

16729-422-01 1 TUBE in 1 CARTON (16729-422-01) / 100 g in 1 TUBE 16729-422-10 1 TUBE in 1 CARTON (16729-422-10) / 30 g in 1 TUBE 16729-422-12 1 TUBE in 1 CARTON (16729-422-12) / 60 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": "23a804e6-2854-6b9b-e063-6394a90af669", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["313189", "314266"], "spl_set_id": ["80e6817a-9b1e-4f0f-e053-2a91aa0a3d15"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (16729-422-01)  / 100 g in 1 TUBE", "package_ndc": "16729-422-01", "marketing_start_date": "20190605"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16729-422-10)  / 30 g in 1 TUBE", "package_ndc": "16729-422-10", "marketing_start_date": "20190531"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16729-422-12)  / 60 g in 1 TUBE", "package_ndc": "16729-422-12", "marketing_start_date": "20190531"}], "brand_name": "Tacrolimus", "product_id": "16729-422_23a804e6-2854-6b9b-e063-6394a90af669", "dosage_form": "OINTMENT", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "16729-422", "generic_name": "Tacrolimus", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/g"}], "application_number": "ANDA211688", "marketing_category": "ANDA", "marketing_start_date": "20190531", "listing_expiration_date": "20261231"}