Tacrolimus

Product NDC
14789-135
11-digit product format
147890135
Labeler code
14789
Product ID
14789-135_44fc0987-ff9d-3099-e063-6394a90a7a55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Nexus Pharmaceuticals, LLC
Application
ANDA217108
Marketing category
ANDA
Marketing start
2025-12-01
Substance
TACROLIMUS
Active strength
5 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui198379

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
14789-135-05Tacrolimus10 in 1 CARTONINJECTION1011
14789-135-07Tacrolimus1 mL in 1 VIALINJECTION111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198379tacrolimus 5 MG in 1 ML InjectionPSN9d502961-e9c0-4611-92bf-ce742a7b962c11
1983791 ML tacrolimus 5 MG/ML InjectionSCD9d502961-e9c0-4611-92bf-ce742a7b962c11
198379tacrolimus 5 MG per 1 ML InjectionSY9d502961-e9c0-4611-92bf-ce742a7b962c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14789-135-051478901350510 VIAL in 1 CARTON (14789-135-05) / 1 mL in 1 VIAL (14789-135-07) 10 vial2025-12-01NoNoCurrent
14789-135-07147890135071 mL in 1 VIAL1 mlHistorical