prograf

Generic: tacrolimus

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prograf
Generic Name tacrolimus
Labeler astellas pharma us, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tacrolimus 5 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-3016
Product ID 0469-3016_e9157663-1515-4ba3-83b5-1622cf6f0f99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050709
Listing Expiration 2026-12-31
Marketing Start 1994-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04693016
Hyphenated Format 0469-3016

Supplemental Identifiers

RxCUI
108513 108514 108515 198377 198378 198379 261134 313190 2052605 2052609 2052703 2052704
UPC
0304690607731 0304690657736 0304691230501 0304691330508 0304690617730 0304693016011
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 prograf (source: ndc)
Generic Name tacrolimus (source: ndc)
Application Number NDA050709 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 BOX (0469-3016-01) / 1 mL in 1 AMPULE
source: ndc

Packages (1)

0469-3016-01 10 AMPULE in 1 BOX (0469-3016-01) / 1 mL in 1 AMPULE

Ingredients (1)

tacrolimus (5 mg/mL)

Linked Drug Pages (1)

Prograf ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e9157663-1515-4ba3-83b5-1622cf6f0f99", "openfda": {"upc": ["0304690607731", "0304690657736", "0304691230501", "0304691330508", "0304690617730", "0304693016011"], "unii": ["WM0HAQ4WNM"], "rxcui": ["108513", "108514", "108515", "198377", "198378", "198379", "261134", "313190", "2052605", "2052609", "2052703", "2052704"], "spl_set_id": ["7f667de1-9dfa-4bd6-8ba0-15ee2d78873b"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 BOX (0469-3016-01)  / 1 mL in 1 AMPULE", "package_ndc": "0469-3016-01", "marketing_start_date": "19940408"}], "brand_name": "Prograf", "product_id": "0469-3016_e9157663-1515-4ba3-83b5-1622cf6f0f99", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0469-3016", "generic_name": "Tacrolimus", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prograf", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/mL"}], "application_number": "NDA050709", "marketing_category": "NDA", "marketing_start_date": "19940408", "listing_expiration_date": "20261231"}