tacrolimus

Generic: tacrolimus

Labeler: concord biotech limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler concord biotech limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 1 mg/1

Manufacturer
CONCORD BIOTECH LIMITED

Identifiers & Regulatory

Product NDC 68254-5005
Product ID 68254-5005_76ffdfc1-7f00-49da-9578-5352593b4830
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213112
Listing Expiration 2026-12-31
Marketing Start 2020-11-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 682545005
Hyphenated Format 68254-5005

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0368254500418 0368254500616 0368254500517
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 ANDA213112 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68254-5005-1)
  • 30 CAPSULE in 1 BOTTLE (68254-5005-5)
source: ndc

Packages (2)

68254-5005-1 100 CAPSULE in 1 BOTTLE (68254-5005-1) 68254-5005-5 30 CAPSULE in 1 BOTTLE (68254-5005-5)

Ingredients (1)

tacrolimus (1 mg/1)

Linked Drug Pages (1)

Tacrolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "76ffdfc1-7f00-49da-9578-5352593b4830", "openfda": {"upc": ["0368254500418", "0368254500616", "0368254500517"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["823b11cb-d873-4017-a861-d22d2c5a8a49"], "manufacturer_name": ["CONCORD BIOTECH LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68254-5005-1)", "package_ndc": "68254-5005-1", "marketing_start_date": "20201123"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68254-5005-5)", "package_ndc": "68254-5005-5", "marketing_start_date": "20201123"}], "brand_name": "Tacrolimus", "product_id": "68254-5005_76ffdfc1-7f00-49da-9578-5352593b4830", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68254-5005", "generic_name": "Tacrolimus", "labeler_name": "CONCORD BIOTECH LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA213112", "marketing_category": "ANDA", "marketing_start_date": "20201123", "listing_expiration_date": "20261231"}