tacrolimus

Generic: tacrolimus

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 1 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-032
Product ID 82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065461
Listing Expiration 2026-12-31
Marketing Start 2009-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804032
Hyphenated Format 82804-032

Supplemental Identifiers

RxCUI
198377
UPC
0382804032303
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 (82804-032-30)
  • 60 CAPSULE in 1 BOTTLE (82804-032-60)
  • 90 CAPSULE in 1 BOTTLE (82804-032-90)
source: ndc

Packages (3)

82804-032-30 30 CAPSULE in 1 BOTTLE (82804-032-30) 82804-032-60 60 CAPSULE in 1 BOTTLE (82804-032-60) 82804-032-90 90 CAPSULE in 1 BOTTLE (82804-032-90)

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": "20d1c12a-bf4b-4467-93a0-ee8b892abea9", "openfda": {"upc": ["0382804032303"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377"], "spl_set_id": ["20d1c12a-bf4b-4467-93a0-ee8b892abea9"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (82804-032-30)", "package_ndc": "82804-032-30", "marketing_start_date": "20231025"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (82804-032-60)", "package_ndc": "82804-032-60", "marketing_start_date": "20231025"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (82804-032-90)", "package_ndc": "82804-032-90", "marketing_start_date": "20231025"}], "brand_name": "Tacrolimus", "product_id": "82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "82804-032", "generic_name": "Tacrolimus", "labeler_name": "Proficient Rx LP", "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": "20090810", "listing_expiration_date": "20261231"}