Tacrolimus

Product NDC
63629-9581
11-digit product format
636299581
Labeler code
63629
Product ID
63629-9581_ac97eece-fd7a-429c-bc21-3391cfd28b66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065461
Marketing category
ANDA
Marketing start
2009-08-10
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
63629-9581-1Tacrolimus60 in 1 BOTTLECAPSULE60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9581TACROLIMUS CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240913_976f1b69-dd96-4815-b11b-839ce1c45633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN976f1b69-dd96-4815-b11b-839ce1c45633102
313190tacrolimus 0.5 MG Oral CapsuleSCD976f1b69-dd96-4815-b11b-839ce1c45633102
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY976f1b69-dd96-4815-b11b-839ce1c45633102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9581-16362995810160 CAPSULE in 1 BOTTLE (63629-9581-1) 60 capsule2023-08-21NoNoCurrent