FDA.reportPublic FDA data

Tacrolimus

Product NDC
0781-2104
11-digit product format
007812104
Labeler code
0781
Product ID
0781-2104_8f214e2d-762b-4a1b-bf23-0f784d91a8c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc.
Application
ANDA065461
Marketing category
ANDA
Marketing start
2009-08-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2104-01Tacrolimus100 in 1 BOTTLECAPSULE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2104-01EA - Each0781-2104b2894e76-74e5-4a97-8a9f-91d90875c6b012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [SANDOZ INC]10
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [SANDOZ INC]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XTACROLIMUS CAPSULE [SANDOZ INC]10
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TACROLIMUS CAPSULE [SANDOZ INC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [SANDOZ INC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TACROLIMUS CAPSULE [SANDOZ INC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [SANDOZ INC]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TACROLIMUS CAPSULE [SANDOZ INC]10
GELATININACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [SANDOZ INC]10
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KTACROLIMUS CAPSULE [SANDOZ INC]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [SANDOZ INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [SANDOZ INC]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTACROLIMUS CAPSULE [SANDOZ INC]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TACROLIMUS CAPSULE [SANDOZ INC]10
SHELLACINACTIVE INGREDIENT46N107B71OTACROLIMUS CAPSULE [SANDOZ INC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [SANDOZ INC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2104TACROLIMUS CAPSULE [SANDOZ INC]21Current NDC, Legacy NDC, 1 package rows20240814_46ac55cf-d85e-4c34-bb33-f49e078c4a03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198378tacrolimus 5 MG Oral CapsulePSN27154d3a-eec5-4000-a4ff-bfbfe27eb806104
198378tacrolimus 5 MG Oral CapsuleSCD27154d3a-eec5-4000-a4ff-bfbfe27eb806104
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY27154d3a-eec5-4000-a4ff-bfbfe27eb806104
313190tacrolimus 0.5 MG Oral CapsulePSN46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198377tacrolimus 1 MG Oral CapsulePSN46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198378tacrolimus 5 MG Oral CapsulePSN46ac55cf-d85e-4c34-bb33-f49e078c4a0322
313190tacrolimus 0.5 MG Oral CapsuleSCD46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198377tacrolimus 1 MG Oral CapsuleSCD46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198378tacrolimus 5 MG Oral CapsuleSCD46ac55cf-d85e-4c34-bb33-f49e078c4a0322
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY46ac55cf-d85e-4c34-bb33-f49e078c4a0322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2104-0100781210401100 CAPSULE in 1 BOTTLE (0781-2104-01) 100 capsule2009-08-100000-00-00NoNoCurrent