Tacrolimus

Product NDC
63629-8723
11-digit product format
636298723
Labeler code
63629
Product ID
63629-8723_12dee664-9577-4318-9817-faf51b41e8b4
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
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
63629-8723-1Tacrolimus100 in 1 BOTTLECAPSULE100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8723-1EA - Each63629-87239039f87c-6431-4703-8c3f-5bbde5786bce12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8723TACROLIMUS CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240912_3dc347e3-9bfd-4910-adb5-24e979208345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198377tacrolimus 1 MG Oral CapsulePSN3dc347e3-9bfd-4910-adb5-24e979208345105
198377tacrolimus 1 MG Oral CapsuleSCD3dc347e3-9bfd-4910-adb5-24e979208345105
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY3dc347e3-9bfd-4910-adb5-24e979208345105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8723-163629872301100 CAPSULE in 1 BOTTLE (63629-8723-1) 100 capsule2024-09-050000-00-00NoNoCurrent