FDA.reportPublic FDA data

Tacrolimus

Product NDC
68084-449
11-digit product format
680840449
Labeler code
68084
Product ID
68084-449_249a483c-c5c4-11c3-e063-6394a90a0e2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090509
Marketing category
ANDA
Marketing start
2010-08-03
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
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
68084-449-01Tacrolimus100 in 1 BOX, UNIT-DOSECAPSULE10018
68084-449-11Tacrolimus1 in 1 BLISTER PACKCAPSULE118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-449-01EA - Each68084-449d50a22c3-f532-4d2c-b8a0-2bc91190c6be12012-07-24
68084-449-11EA - Each68084-449de04a7d2-a9dd-4763-9e6b-bcdae8b1a3f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tacrolimusACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
ferric oxide redINACTIVE INGREDIENT1K09F3G675TACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
gelatinINACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
magnesium stearateINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-449TACROLIMUS CAPSULE [AMERICAN HEALTH PACKAGING]18Current NDC, Legacy NDC, 2 package rows20241025_93d03943-0655-44f6-b494-57bd1e336a34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN93d03943-0655-44f6-b494-57bd1e336a3418
198377tacrolimus 1 MG Oral CapsulePSN93d03943-0655-44f6-b494-57bd1e336a3418
198378tacrolimus 5 MG Oral CapsulePSN93d03943-0655-44f6-b494-57bd1e336a3418
313190tacrolimus 0.5 MG Oral CapsuleSCD93d03943-0655-44f6-b494-57bd1e336a3418
198377tacrolimus 1 MG Oral CapsuleSCD93d03943-0655-44f6-b494-57bd1e336a3418
198378tacrolimus 5 MG Oral CapsuleSCD93d03943-0655-44f6-b494-57bd1e336a3418
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY93d03943-0655-44f6-b494-57bd1e336a3418
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY93d03943-0655-44f6-b494-57bd1e336a3418
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY93d03943-0655-44f6-b494-57bd1e336a3418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-449-0168084044901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-449-01) / 1 CAPSULE in 1 BLISTER PACK (68084-449-11) 100 blister pack2010-08-030000-00-00NoNoCurrent
68084-449-11680840449111 in 1 BLISTER PACKHistorical