tacrolimus

Generic: tacrolimus

Labeler: panacea biotec limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler panacea biotec limited
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Panacea Biotec Limited

Identifiers & Regulatory

Product NDC 43817-421
Product ID 43817-421_778cec6b-16f1-47b0-9c97-113ea026b5e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090802
Listing Expiration 2026-12-31
Marketing Start 2016-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43817421
Hyphenated Format 43817-421

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0343817423014 0343817421010 0343817422017
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 (43817-421-01)
source: ndc

Packages (1)

43817-421-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01)

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": "778cec6b-16f1-47b0-9c97-113ea026b5e5", "openfda": {"upc": ["0343817423014", "0343817421010", "0343817422017"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["bd9fea26-0236-d437-c7df-4b7636210875"], "manufacturer_name": ["Panacea Biotec Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01)", "package_ndc": "43817-421-01", "marketing_start_date": "20160226"}], "brand_name": "Tacrolimus", "product_id": "43817-421_778cec6b-16f1-47b0-9c97-113ea026b5e5", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "43817-421", "generic_name": "Tacrolimus", "labeler_name": "Panacea Biotec Limited", "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": "20160226", "listing_expiration_date": "20261231"}