tacrolimus

Generic: tacrolimus

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler american health packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-451
Product ID 68084-451_249a483c-c5c4-11c3-e063-6394a90a0e2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090509
Listing Expiration 2026-12-31
Marketing Start 2010-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084451
Hyphenated Format 68084-451

Supplemental Identifiers

RxCUI
198377 198378 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 ANDA090509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-451-01) / 1 CAPSULE in 1 BLISTER PACK (68084-451-11)
source: ndc

Packages (1)

68084-451-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-451-01) / 1 CAPSULE in 1 BLISTER PACK (68084-451-11)

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": "249a483c-c5c4-11c3-e063-6394a90a0e2e", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["93d03943-0655-44f6-b494-57bd1e336a34"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-451-01)  / 1 CAPSULE in 1 BLISTER PACK (68084-451-11)", "package_ndc": "68084-451-01", "marketing_start_date": "20100803"}], "brand_name": "Tacrolimus", "product_id": "68084-451_249a483c-c5c4-11c3-e063-6394a90a0e2e", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68084-451", "generic_name": "Tacrolimus", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA090509", "marketing_category": "ANDA", "marketing_start_date": "20100803", "listing_expiration_date": "20261231"}