tacrolimus

Generic: tacrolimus

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-278
Product ID 67877-278_46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203740
Listing Expiration 2026-12-31
Marketing Start 2020-11-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877278
Hyphenated Format 67877-278

Supplemental Identifiers

RxCUI
198377 198378 313190
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 ANDA203740 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (67877-278-01)
  • 50 BLISTER PACK in 1 CARTON (67877-278-33) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

67877-278-01 100 CAPSULE in 1 BOTTLE (67877-278-01) 67877-278-33 50 BLISTER PACK in 1 CARTON (67877-278-33) / 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": "46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["55467f4b-8437-43a3-b6d9-1bc2a13b4c11"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (67877-278-01)", "package_ndc": "67877-278-01", "marketing_start_date": "20201113"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (67877-278-33)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-278-33", "marketing_start_date": "20201113"}], "brand_name": "Tacrolimus", "product_id": "67877-278_46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "67877-278", "generic_name": "Tacrolimus", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA203740", "marketing_category": "ANDA", "marketing_start_date": "20201113", "listing_expiration_date": "20261231"}