tacrolimus

Generic: tacrolimus

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

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2047
Product ID 0378-2047_7d8a5bab-a744-4aa7-b28f-d0c2c5a53628
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090596
Listing Expiration 2026-12-31
Marketing Start 2010-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03782047
Hyphenated Format 0378-2047

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0303782046014 0303782045017 0303782047011
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 ANDA090596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2047-01)
source: ndc

Packages (1)

0378-2047-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2047-01)

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": "7d8a5bab-a744-4aa7-b28f-d0c2c5a53628", "openfda": {"upc": ["0303782046014", "0303782045017", "0303782047011"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["45af3eda-caaa-4478-9372-95aa65adc9b3"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2047-01)", "package_ndc": "0378-2047-01", "marketing_start_date": "20100917"}], "brand_name": "Tacrolimus", "product_id": "0378-2047_7d8a5bab-a744-4aa7-b28f-d0c2c5a53628", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0378-2047", "generic_name": "Tacrolimus", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA090596", "marketing_category": "ANDA", "marketing_start_date": "20100917", "listing_expiration_date": "20261231"}