FDA.reportPublic FDA data

tacrolimus

Product NDC
71432-2003
11-digit product format
714322003
Labeler code
71432
Product ID
71432-2003_102bdf7c-9d79-0124-e063-6394a90aced9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus extended-release capsules
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Chengdu Suncadia Medicine Co., Ltd.
Application
ANDA215012
Marketing category
ANDA
Marketing start
2024-01-25
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
Rxcui1431971, 1431980, 1431985

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
71432-2003-1tacrolimus5 in 1 BAGCAPSULE, COATED, EXTENDED RELEAS55
71432-2003-1tacrolimus1 in 1 CARTONCAPSULE, COATED, EXTENDED RELEAS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71432-2003TACROLIMUS (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [CHENGDU SUNCADIA MEDICINE CO., LTD.]5Current NDC, 2 package rows20240213_08cf2861-2483-405d-a872-a88a5c235f9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431971tacrolimus 0.5 MG 24HR Extended Release Oral CapsulePSN08cf2861-2483-405d-a872-a88a5c235f9a5
1431980tacrolimus 1 MG 24HR Extended Release Oral CapsulePSN08cf2861-2483-405d-a872-a88a5c235f9a5
1431985tacrolimus 5 MG 24HR Extended Release Oral CapsulePSN08cf2861-2483-405d-a872-a88a5c235f9a5
143197124 HR tacrolimus 0.5 MG Extended Release Oral CapsuleSCD08cf2861-2483-405d-a872-a88a5c235f9a5
143198024 HR tacrolimus 1 MG Extended Release Oral CapsuleSCD08cf2861-2483-405d-a872-a88a5c235f9a5
143198524 HR tacrolimus 5 MG Extended Release Oral CapsuleSCD08cf2861-2483-405d-a872-a88a5c235f9a5
1431971tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY08cf2861-2483-405d-a872-a88a5c235f9a5
1431980tacrolimus 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY08cf2861-2483-405d-a872-a88a5c235f9a5
1431985tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY08cf2861-2483-405d-a872-a88a5c235f9a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71432-2003-1714322003011 BAG in 1 CARTON (71432-2003-1) / 5 BLISTER PACK in 1 BAG / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK1 bag2024-01-25NoNoCurrent