tacrolimus

Generic: tacrolimus

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

Drug Facts

Product Profile

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

tacrolimus 5 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-043
Product ID 16729-043_3622f4f5-48bd-9035-e063-6294a90afac2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091195
Listing Expiration 2026-12-31
Marketing Start 2011-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729043
Hyphenated Format 16729-043

Supplemental Identifiers

RxCUI
2665161 2665162 2665163
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 ANDA091195 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (16729-043-01)
source: ndc

Packages (1)

16729-043-01 100 CAPSULE in 1 BOTTLE (16729-043-01)

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": "3622f4f5-48bd-9035-e063-6294a90afac2", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["2665161", "2665162", "2665163"], "spl_set_id": ["bd447ffa-9196-4c3c-accf-5adf29b84665"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16729-043-01)", "package_ndc": "16729-043-01", "marketing_start_date": "20110930"}], "brand_name": "Tacrolimus", "product_id": "16729-043_3622f4f5-48bd-9035-e063-6294a90afac2", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "16729-043", "generic_name": "Tacrolimus", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA091195", "marketing_category": "ANDA", "marketing_start_date": "20110930", "listing_expiration_date": "20261231"}