tacrolimus

Generic: tacrolimus

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 1 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-054
Product ID 82009-054_3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090509
Listing Expiration 2026-12-31
Marketing Start 2023-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009054
Hyphenated Format 82009-054

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0382009165011 0382009054018 0382009164014
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 ANDA090509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (82009-054-01)
source: ndc

Packages (1)

82009-054-01 100 CAPSULE in 1 BOTTLE (82009-054-01)

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": "3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a", "openfda": {"upc": ["0382009165011", "0382009054018", "0382009164014"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["23b7b4d7-1431-e9f2-43ba-eabd169dc2dd"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (82009-054-01)", "package_ndc": "82009-054-01", "marketing_start_date": "20230720"}], "brand_name": "Tacrolimus", "product_id": "82009-054_3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "82009-054", "generic_name": "Tacrolimus", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA090509", "marketing_category": "ANDA", "marketing_start_date": "20230720", "listing_expiration_date": "20261231"}