FDA.reportPublic FDA data

Tacrolimus

Product NDC
0378-2046
11-digit product format
003782046
Labeler code
0378
Product ID
0378-2046_7d8a5bab-a744-4aa7-b28f-d0c2c5a53628
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090596
Marketing category
ANDA
Marketing start
2010-09-17
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, 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
0378-2046-01Tacrolimus100 in 1 BOTTLE, PLASTICCAPSULE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2046-01EA - Each0378-20465a0643a1-7a94-411d-90ab-2a4929f27eb812012-07-24
0378-2046-05EA - Each0378-2046e126af7a-a9ce-45b0-89d8-9e67f44ed71412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
GELATININACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]4
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2046TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20250328_45af3eda-caaa-4478-9372-95aa65adc9b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN45af3eda-caaa-4478-9372-95aa65adc9b322
198377tacrolimus 1 MG Oral CapsulePSN45af3eda-caaa-4478-9372-95aa65adc9b322
198378tacrolimus 5 MG Oral CapsulePSN45af3eda-caaa-4478-9372-95aa65adc9b322
313190tacrolimus 0.5 MG Oral CapsuleSCD45af3eda-caaa-4478-9372-95aa65adc9b322
198377tacrolimus 1 MG Oral CapsuleSCD45af3eda-caaa-4478-9372-95aa65adc9b322
198378tacrolimus 5 MG Oral CapsuleSCD45af3eda-caaa-4478-9372-95aa65adc9b322
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY45af3eda-caaa-4478-9372-95aa65adc9b322
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY45af3eda-caaa-4478-9372-95aa65adc9b322
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY45af3eda-caaa-4478-9372-95aa65adc9b322
313190tacrolimus 0.5 MG Oral CapsulePSN5f742224-618e-4f4c-bdec-7693be99c69718
198377tacrolimus 1 MG Oral CapsulePSN5f742224-618e-4f4c-bdec-7693be99c69718
198378tacrolimus 5 MG Oral CapsulePSN5f742224-618e-4f4c-bdec-7693be99c69718
313190tacrolimus 0.5 MG Oral CapsuleSCD5f742224-618e-4f4c-bdec-7693be99c69718
198377tacrolimus 1 MG Oral CapsuleSCD5f742224-618e-4f4c-bdec-7693be99c69718
198378tacrolimus 5 MG Oral CapsuleSCD5f742224-618e-4f4c-bdec-7693be99c69718
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY5f742224-618e-4f4c-bdec-7693be99c69718
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY5f742224-618e-4f4c-bdec-7693be99c69718
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY5f742224-618e-4f4c-bdec-7693be99c69718
313190tacrolimus 0.5 MG Oral CapsulePSN34ec4989-6933-4237-ae1e-50a0cb90a2fe13
198377tacrolimus 1 MG Oral CapsulePSN34ec4989-6933-4237-ae1e-50a0cb90a2fe13
198378tacrolimus 5 MG Oral CapsulePSN34ec4989-6933-4237-ae1e-50a0cb90a2fe13
313190tacrolimus 0.5 MG Oral CapsuleSCD34ec4989-6933-4237-ae1e-50a0cb90a2fe13
198377tacrolimus 1 MG Oral CapsuleSCD34ec4989-6933-4237-ae1e-50a0cb90a2fe13
198378tacrolimus 5 MG Oral CapsuleSCD34ec4989-6933-4237-ae1e-50a0cb90a2fe13
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY34ec4989-6933-4237-ae1e-50a0cb90a2fe13
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY34ec4989-6933-4237-ae1e-50a0cb90a2fe13
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY34ec4989-6933-4237-ae1e-50a0cb90a2fe13
313190tacrolimus 0.5 MG Oral CapsulePSN393cd10e-133c-4d6b-b024-270eb82edbb33
198377tacrolimus 1 MG Oral CapsulePSN393cd10e-133c-4d6b-b024-270eb82edbb33
198378tacrolimus 5 MG Oral CapsulePSN393cd10e-133c-4d6b-b024-270eb82edbb33
313190tacrolimus 0.5 MG Oral CapsuleSCD393cd10e-133c-4d6b-b024-270eb82edbb33
198377tacrolimus 1 MG Oral CapsuleSCD393cd10e-133c-4d6b-b024-270eb82edbb33
198378tacrolimus 5 MG Oral CapsuleSCD393cd10e-133c-4d6b-b024-270eb82edbb33
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY393cd10e-133c-4d6b-b024-270eb82edbb33
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY393cd10e-133c-4d6b-b024-270eb82edbb33
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY393cd10e-133c-4d6b-b024-270eb82edbb33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-2046-0100378204601100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2046-01) 100 capsule2010-09-170000-00-00NoNoCurrent