FDA.reportPublic FDA data

tacrolimus

Product NDC
50090-5581
11-digit product format
500905581
Labeler code
50090
Product ID
50090-5581_4548ea65-4102-4f51-864d-d9dfafd7c5ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206662
Marketing category
ANDA
Marketing start
2020-11-10
Substance
TACROLIMUS
Active strength
1 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
TACROLIMUS1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui198377

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
50090-5581-02024-10-21C16284748780-1f386c649-b0be-0266-e053-dadaa90a7c1aThese 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
50090-5581-02023-01-30C16284748780-1f386c649-b0be-0266-e053-dadaa90a7c1aThese 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
50090-5581-0tacrolimus90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5581-0EA - Each50090-5581e1e267d9-b564-44c8-ac29-f03c59950fea12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5581TACROLIMUS CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20241023_3519febc-c9df-4559-b07a-92f8b0c7e770.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198377tacrolimus 1 MG Oral CapsulePSN3519febc-c9df-4559-b07a-92f8b0c7e7703
198377tacrolimus 1 MG Oral CapsuleSCD3519febc-c9df-4559-b07a-92f8b0c7e7703
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY3519febc-c9df-4559-b07a-92f8b0c7e7703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5581-05009055810090 CAPSULE in 1 BOTTLE (50090-5581-0) 90 capsule2021-07-060000-00-00NoNoCurrent