tacrolimus

Generic: tacrolimus

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

Drug Facts

Product Profile

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

tacrolimus 1 mg/1

Manufacturer
Ajenat Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 82983-401
Product ID 82983-401_6b08720e-dc88-4731-8863-af564a293b5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206651
Listing Expiration 2026-12-31
Marketing Start 2023-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82983401
Hyphenated Format 82983-401

Supplemental Identifiers

RxCUI
198377 198378 313190
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 ANDA206651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (82983-401-10)
source: ndc

Packages (1)

82983-401-10 100 CAPSULE in 1 BOTTLE (82983-401-10)

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": "6b08720e-dc88-4731-8863-af564a293b5a", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["ca08d4aa-3de2-4a9d-9554-6288e5d36f29"], "manufacturer_name": ["Ajenat Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (82983-401-10)", "package_ndc": "82983-401-10", "marketing_start_date": "20230131"}], "brand_name": "Tacrolimus", "product_id": "82983-401_6b08720e-dc88-4731-8863-af564a293b5a", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "82983-401", "generic_name": "Tacrolimus", "labeler_name": "Ajenat Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA206651", "marketing_category": "ANDA", "marketing_start_date": "20230131", "listing_expiration_date": "20261231"}