tacrolimus

Generic: tacrolimus

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 1 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-317
Product ID 43353-317_815744b6-6096-4a89-8171-cdca95e10631
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090596
Listing Expiration 2026-12-31
Marketing Start 2015-11-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353317
Hyphenated Format 43353-317

Supplemental Identifiers

RxCUI
198377
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 ANDA090596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09)
source: ndc

Packages (1)

43353-317-09 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09)

Ingredients (1)

tacrolimus (1 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": "815744b6-6096-4a89-8171-cdca95e10631", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198377"], "spl_set_id": ["4caa20af-45a8-4365-9f06-1568afae61b1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09)", "package_ndc": "43353-317-09", "marketing_start_date": "20170503"}], "brand_name": "Tacrolimus", "product_id": "43353-317_815744b6-6096-4a89-8171-cdca95e10631", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "43353-317", "generic_name": "Tacrolimus", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA090596", "marketing_category": "ANDA", "marketing_start_date": "20151118", "listing_expiration_date": "20261231"}