tacrolimus

Generic: tacrolimus

Labeler: nexus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler nexus pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

tacrolimus 5 mg/mL

Manufacturer
Nexus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 14789-135
Product ID 14789-135_44fc0987-ff9d-3099-e063-6394a90a7a55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217108
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14789135
Hyphenated Format 14789-135

Supplemental Identifiers

RxCUI
198379
UPC
0314789135052
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 ANDA217108 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (14789-135-05) / 1 mL in 1 VIAL (14789-135-07)
source: ndc

Packages (1)

14789-135-05 10 VIAL in 1 CARTON (14789-135-05) / 1 mL in 1 VIAL (14789-135-07)

Ingredients (1)

tacrolimus (5 mg/mL)

Linked Drug Pages (1)

Tacrolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "44fc0987-ff9d-3099-e063-6394a90a7a55", "openfda": {"upc": ["0314789135052"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198379"], "spl_set_id": ["9d502961-e9c0-4611-92bf-ce742a7b962c"], "manufacturer_name": ["Nexus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (14789-135-05)  / 1 mL in 1 VIAL (14789-135-07)", "package_ndc": "14789-135-05", "marketing_start_date": "20251201"}], "brand_name": "Tacrolimus", "product_id": "14789-135_44fc0987-ff9d-3099-e063-6394a90a7a55", "dosage_form": "INJECTION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "14789-135", "generic_name": "Tacrolimus", "labeler_name": "Nexus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/mL"}], "application_number": "ANDA217108", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}