Tacrolimus

Product NDC
55154-4080
11-digit product format
551544080
Labeler code
55154
Product ID
55154-4080_ca8ee944-9f6f-4fe2-8d52-391d163301ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA212297
Marketing category
ANDA
Marketing start
2020-12-23
Substance
TACROLIMUS
Active strength
1 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tacrolimus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui198377

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
55154-4080-8Tacrolimus2000 in 1 BOTTLECAPSULE20007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4080TACROLIMUS CAPSULE [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 1 package rows20241013_e898ee90-faae-42a8-b652-be1c8730d856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198377tacrolimus 1 MG Oral CapsulePSNe898ee90-faae-42a8-b652-be1c8730d8567
198377tacrolimus 1 MG Oral CapsuleSCDe898ee90-faae-42a8-b652-be1c8730d8567
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSYe898ee90-faae-42a8-b652-be1c8730d8567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4080-8551544080082000 CAPSULE in 1 BOTTLE (55154-4080-8) 2000 capsule2020-12-230000-00-00NoNoCurrent