Tacrolimus

Product NDC
71335-2189
11-digit product format
713352189
Labeler code
71335
Product ID
71335-2189_bcd0e46a-cabb-4a0d-81c8-f41368a3bd74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091195
Marketing category
ANDA
Marketing start
2011-09-30
Substance
TACROLIMUS
Active strength
.5 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
TACROLIMUS.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui313190

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
71335-2189-1Tacrolimus60 in 1 BOTTLECAPSULE60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2189TACROLIMUS CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240420_a2e55495-10cc-4f6e-b866-1e7d6e45888b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSNa2e55495-10cc-4f6e-b866-1e7d6e45888b103
313190tacrolimus 0.5 MG Oral CapsuleSCDa2e55495-10cc-4f6e-b866-1e7d6e45888b103
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSYa2e55495-10cc-4f6e-b866-1e7d6e45888b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2189-17133521890160 CAPSULE in 1 BOTTLE (71335-2189-1) 60 capsule2022-11-03NoNoHistorical