tacrolimus

Generic: tacrolimus

Labeler: stellon biotech. inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler stellon biotech. inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 5 mg/1

Manufacturer
Stellon Biotech. Inc.

Identifiers & Regulatory

Product NDC 85972-103
Product ID 85972-103_e2323d67-bab2-4dbd-be2f-9ca240c98737
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213112
Listing Expiration 2026-12-31
Marketing Start 2025-08-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85972103
Hyphenated Format 85972-103

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0385972103011 0385972101017 0385972102014
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
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (85972-103-01)
  • 30 CAPSULE in 1 BOTTLE (85972-103-30)
source: ndc

Packages (2)

85972-103-01 100 CAPSULE in 1 BOTTLE (85972-103-01) 85972-103-30 30 CAPSULE in 1 BOTTLE (85972-103-30)

Ingredients (1)

tacrolimus (5 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": "e2323d67-bab2-4dbd-be2f-9ca240c98737", "openfda": {"upc": ["0385972103011", "0385972101017", "0385972102014"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["6b89e8a4-9f11-42e3-8e79-fe617e7c461f"], "manufacturer_name": ["Stellon Biotech. Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (85972-103-01)", "package_ndc": "85972-103-01", "marketing_start_date": "20250807"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (85972-103-30)", "package_ndc": "85972-103-30", "marketing_start_date": "20250807"}], "brand_name": "Tacrolimus", "product_id": "85972-103_e2323d67-bab2-4dbd-be2f-9ca240c98737", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "85972-103", "generic_name": "Tacrolimus", "labeler_name": "Stellon Biotech. Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA213112", "marketing_category": "ANDA", "marketing_start_date": "20250807", "listing_expiration_date": "20261231"}