FDA.reportPublic FDA data

Tacrolimus

Product NDC
82983-402
11-digit product format
829830402
Labeler code
82983
Product ID
82983-402_6b08720e-dc88-4731-8863-af564a293b5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Ajenat Pharmaceuticals LLC
Application
ANDA206651
Marketing category
ANDA
Marketing start
2023-01-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82983-402-102025-02-11C16284748780-12cef2736-6a36-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES.TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994
82983-402-102025-01-30C16284748780-12cef2736-6a36-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES.TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82983-402-10Tacrolimus100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82983-402-10EA - Each82983-402886bf75e-2a2d-462f-ac4b-6b23e840d1f412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82983-402TACROLIMUS CAPSULE [AJENAT PHARMACEUTICALS LLC]2Current NDC, 1 package rows20250213_ca08d4aa-3de2-4a9d-9554-6288e5d36f29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSNca08d4aa-3de2-4a9d-9554-6288e5d36f294
198377tacrolimus 1 MG Oral CapsulePSNca08d4aa-3de2-4a9d-9554-6288e5d36f294
198378tacrolimus 5 MG Oral CapsulePSNca08d4aa-3de2-4a9d-9554-6288e5d36f294
313190tacrolimus 0.5 MG Oral CapsuleSCDca08d4aa-3de2-4a9d-9554-6288e5d36f294
198377tacrolimus 1 MG Oral CapsuleSCDca08d4aa-3de2-4a9d-9554-6288e5d36f294
198378tacrolimus 5 MG Oral CapsuleSCDca08d4aa-3de2-4a9d-9554-6288e5d36f294
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSYca08d4aa-3de2-4a9d-9554-6288e5d36f294
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSYca08d4aa-3de2-4a9d-9554-6288e5d36f294
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSYca08d4aa-3de2-4a9d-9554-6288e5d36f294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82983-402-1082983040210100 CAPSULE in 1 BOTTLE (82983-402-10) 100 capsule2023-01-31NoNoHistorical