tacrolimus

Generic: tacrolimus

Labeler: jubilant cadista pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler jubilant cadista pharmaceuticals inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Jubilant Cadista Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59746-798
Product ID 59746-798_5448715d-4dd1-450f-a945-e111aa55d12e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090802
Listing Expiration 2026-12-31
Marketing Start 2024-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59746798
Hyphenated Format 59746-798

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0359746800017 0359746798017 0359746799014
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 ANDA090802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-798-01)
source: ndc

Packages (1)

59746-798-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-798-01)

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": "5448715d-4dd1-450f-a945-e111aa55d12e", "openfda": {"upc": ["0359746800017", "0359746798017", "0359746799014"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["651bd506-96b0-43e5-a4dd-db03bf9154c9"], "manufacturer_name": ["Jubilant Cadista Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-798-01)", "package_ndc": "59746-798-01", "marketing_start_date": "20241130"}], "brand_name": "Tacrolimus", "product_id": "59746-798_5448715d-4dd1-450f-a945-e111aa55d12e", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "59746-798", "generic_name": "Tacrolimus", "labeler_name": "Jubilant Cadista Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA090802", "marketing_category": "ANDA", "marketing_start_date": "20241130", "listing_expiration_date": "20261231"}