tacrolimus

Generic: tacrolimus

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9581
Product ID 63629-9581_ac97eece-fd7a-429c-bc21-3391cfd28b66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065461
Listing Expiration 2026-12-31
Marketing Start 2009-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299581
Hyphenated Format 63629-9581

Supplemental Identifiers

RxCUI
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 ANDA065461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (63629-9581-1)
source: ndc

Packages (1)

63629-9581-1 60 CAPSULE in 1 BOTTLE (63629-9581-1)

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": "ac97eece-fd7a-429c-bc21-3391cfd28b66", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["313190"], "spl_set_id": ["976f1b69-dd96-4815-b11b-839ce1c45633"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63629-9581-1)", "package_ndc": "63629-9581-1", "marketing_start_date": "20230821"}], "brand_name": "Tacrolimus", "product_id": "63629-9581_ac97eece-fd7a-429c-bc21-3391cfd28b66", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "63629-9581", "generic_name": "Tacrolimus", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA065461", "marketing_category": "ANDA", "marketing_start_date": "20090810", "listing_expiration_date": "20261231"}