tacrolimus

Product NDC
16714-098
11-digit product format
167140098
Labeler code
16714
Product ID
16714-098_a24bfd52-5fd3-4980-8e64-5ba6b0d93d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA206662
Marketing category
ANDA
Marketing start
2021-03-31
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
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
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-098-01tacrolimus100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-098-01EA - Each16714-0981c7b1ded-dcae-4ed7-9eb8-9ff7f39a140112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-098TACROLIMUS CAPSULE [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 1 package rows20231212_875f4962-557e-4e12-ad7b-cb5fb6f2a65f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
198377tacrolimus 1 MG Oral CapsulePSN875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
198378tacrolimus 5 MG Oral CapsulePSN875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
313190tacrolimus 0.5 MG Oral CapsuleSCD875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
198377tacrolimus 1 MG Oral CapsuleSCD875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
198378tacrolimus 5 MG Oral CapsuleSCD875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY875f4962-557e-4e12-ad7b-cb5fb6f2a65f3
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY875f4962-557e-4e12-ad7b-cb5fb6f2a65f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-098-0116714009801100 CAPSULE in 1 BOTTLE (16714-098-01) 100 capsule2021-03-310000-00-00NoNoCurrent