tacrolimus

Generic: tacrolimus

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

Drug Facts

Product Profile

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

tacrolimus .5 mg/1

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 0781-2102
Product ID 0781-2102_8f214e2d-762b-4a1b-bf23-0f784d91a8c2
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 07812102
Hyphenated Format 0781-2102

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0307812103012 0307812102015 0307812104019
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 ANDA065461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0781-2102-01)
source: ndc

Packages (1)

0781-2102-01 100 CAPSULE in 1 BOTTLE (0781-2102-01)

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": "8f214e2d-762b-4a1b-bf23-0f784d91a8c2", "openfda": {"upc": ["0307812103012", "0307812102015", "0307812104019"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["46ac55cf-d85e-4c34-bb33-f49e078c4a03"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0781-2102-01)", "package_ndc": "0781-2102-01", "marketing_start_date": "20090810"}], "brand_name": "Tacrolimus", "product_id": "0781-2102_8f214e2d-762b-4a1b-bf23-0f784d91a8c2", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0781-2102", "generic_name": "Tacrolimus", "labeler_name": "Sandoz Inc.", "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"}