tacrolimus

Generic: tacrolimus

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tacrolimus .5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6623
Product ID 0904-6623_9c3a81c9-20a9-4756-82ad-7ce794c760b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090509
Listing Expiration 2026-12-31
Marketing Start 2010-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046623
Hyphenated Format 0904-6623

Supplemental Identifiers

RxCUI
198378 313190
UNII
WM0HAQ4WNM

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 ANDA090509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6623-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6623-61 100 BLISTER PACK in 1 CARTON (0904-6623-61) / 1 CAPSULE in 1 BLISTER PACK

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": "9c3a81c9-20a9-4756-82ad-7ce794c760b9", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198378", "313190"], "spl_set_id": ["0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6623-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6623-61", "marketing_start_date": "20100514"}], "brand_name": "Tacrolimus", "product_id": "0904-6623_9c3a81c9-20a9-4756-82ad-7ce794c760b9", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0904-6623", "generic_name": "Tacrolimus", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA090509", "marketing_category": "ANDA", "marketing_start_date": "20100514", "listing_expiration_date": "20261231"}