tacrolimus

Generic: tacrolimus

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler direct_rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 1 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-536
Product ID 72189-536_13278868-e3cb-d2d0-e063-6294a90a6533
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065461
Listing Expiration 2026-12-31
Marketing Start 2024-02-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189536
Hyphenated Format 72189-536

Supplemental Identifiers

RxCUI
198377
UNII
WM0HAQ4WNM

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 ANDA065461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72189-536-30)
source: ndc

Packages (1)

72189-536-30 30 CAPSULE in 1 BOTTLE (72189-536-30)

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": "13278868-e3cb-d2d0-e063-6294a90a6533", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198377"], "spl_set_id": ["10ceb3bc-11cc-13e4-e063-6394a90acce4"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72189-536-30)", "package_ndc": "72189-536-30", "marketing_start_date": "20240207"}], "brand_name": "Tacrolimus", "product_id": "72189-536_13278868-e3cb-d2d0-e063-6294a90a6533", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "72189-536", "generic_name": "Tacrolimus", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA065461", "marketing_category": "ANDA", "marketing_start_date": "20240207", "listing_expiration_date": "20261231"}