FDA.reportPublic FDA data

Tacrus

Product NDC
82160-124
Requested package NDC
82160-124-02
11-digit product format
821600124
Labeler code
82160
Product ID
82160-124_d393f707-58f0-dd34-e053-2995a90adc95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-12-11
Marketing end
0000-00-00
Substance
TACROLIMUS
Active strength
30 mg/30g
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82160-12482160-124-02IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-124-01Tacrus30 g in 1 TUBEOINTMENT30128
82160-124-01Tacrus1 in 1 CARTONOINTMENT1128
82160-124-02Tacrus10 g in 1 TUBEOINTMENT10128
82160-124-02Tacrus1 in 1 CARTONOINTMENT1128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-124TACRUS (TACROLIMUS) OINTMENT [PELLA PHARMACEUTICALS CO. LTD]128Legacy NDC, 4 package rows20250101_d0815b7a-46e5-0605-e053-2a95a90a78a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314266tacrolimus 0.1 % Topical OintmentPSNd0815b7a-46e5-0605-e053-2a95a90a78a8128
314266tacrolimus 0.001 MG/MG Topical OintmentSCDd0815b7a-46e5-0605-e053-2a95a90a78a8128
314266tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical OintmentSYd0815b7a-46e5-0605-e053-2a95a90a78a8128
314266tacrolimus 0.1 % Topical OintmentSYd0815b7a-46e5-0605-e053-2a95a90a78a8128

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82160-124-02821600124021 TUBE in 1 CARTON (82160-124-02) > 10 g in 1 TUBE1 tube2014-12-110000-00-00NoNoCurrent