Tacrolimus

Product NDC
54288-134
11-digit product format
542880134
Labeler code
54288
Product ID
54288-134_f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
BPI Labs LLC
Application
ANDA206651
Marketing category
ANDA
Marketing start
2020-04-08
Substance
TACROLIMUS
Active strength
.5 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tacrolimus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui198377, 198378, 313190

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-134-01Tacrolimus100 in 1 BOTTLECAPSULE10012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN3e8bc65e-8048-4073-8e45-57033060300012
198377tacrolimus 1 MG Oral CapsulePSN3e8bc65e-8048-4073-8e45-57033060300012
198378tacrolimus 5 MG Oral CapsulePSN3e8bc65e-8048-4073-8e45-57033060300012
313190tacrolimus 0.5 MG Oral CapsuleSCD3e8bc65e-8048-4073-8e45-57033060300012
198377tacrolimus 1 MG Oral CapsuleSCD3e8bc65e-8048-4073-8e45-57033060300012
198378tacrolimus 5 MG Oral CapsuleSCD3e8bc65e-8048-4073-8e45-57033060300012
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY3e8bc65e-8048-4073-8e45-57033060300012
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY3e8bc65e-8048-4073-8e45-57033060300012
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY3e8bc65e-8048-4073-8e45-57033060300012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-134-0154288013401100 CAPSULE in 1 BOTTLE (54288-134-01) 100 capsule2020-04-08NoNoCurrent