Tacrolimus

Product NDC
63629-9325
11-digit product format
636299325
Labeler code
63629
Product ID
63629-9325_9e1bdc2a-6295-41c7-88d1-8bf1ef908f41
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
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
63629-9325-1Tacrolimus60 in 1 BOTTLECAPSULE60105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9325TACROLIMUS CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240510_54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198377tacrolimus 1 MG Oral CapsulePSN54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6105
198377tacrolimus 1 MG Oral CapsuleSCD54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6105
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9325-16362993250160 CAPSULE in 1 BOTTLE (63629-9325-1) 60 capsule2022-07-110000-00-00NoNoCurrent