Tacrolimus

Product NDC
63629-8726
11-digit product format
636298726
Labeler code
63629
Product ID
63629-8726_5a5566b9-2675-4885-ad48-7cd0f0c8fce5
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
TACROLIMUS5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui198378

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
63629-8726-1Tacrolimus100 in 1 BOTTLECAPSULE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8726-1EA - Each63629-872647212d0c-be22-4618-ac3c-3fe79e32e02712021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8726TACROLIMUS CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240913_27154d3a-eec5-4000-a4ff-bfbfe27eb806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198378tacrolimus 5 MG Oral CapsulePSN27154d3a-eec5-4000-a4ff-bfbfe27eb806104
198378tacrolimus 5 MG Oral CapsuleSCD27154d3a-eec5-4000-a4ff-bfbfe27eb806104
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY27154d3a-eec5-4000-a4ff-bfbfe27eb806104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8726-163629872601100 CAPSULE in 1 BOTTLE (63629-8726-1) 100 capsule2024-09-050000-00-00NoNoCurrent