FDA.reportPublic FDA data

Tacrolimus

Product NDC
55111-525
11-digit product format
551110525
Labeler code
55111
Product ID
55111-525_706bafff-d629-291c-5ce5-83d74a638860
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA090509
Marketing category
ANDA
Marketing start
2010-05-14
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
55111-525-01Tacrolimus1 in 1 CARTONCAPSULE116
55111-525-01Tacrolimus100 in 1 BOTTLECAPSULE10016
55111-525-05Tacrolimus1 in 1 CARTONCAPSULE116
55111-525-05Tacrolimus500 in 1 BOTTLECAPSULE50016
55111-525-30Tacrolimus30 in 1 BOTTLECAPSULE3016
55111-525-30Tacrolimus1 in 1 CARTONCAPSULE116
55111-525-78Tacrolimus10 in 1 CARTONCAPSULE1016
55111-525-79Tacrolimus10 in 1 BLISTER PACKCAPSULE1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-525-01EA - Each55111-5251c28866c-cb71-43b4-9b20-f1152785fc8f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tacrolimusACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
tacrolimus anhydrousACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferric oxide redINACTIVE INGREDIENT1K09F3G675TACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
gelatinINACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
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
55111-525TACROLIMUS CAPSULE [DR. REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 8 package rows20240119_61dee012-43af-0e9a-3843-9b9b91e022c4.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
313190tacrolimus 0.5 MG Oral CapsulePSN61dee012-43af-0e9a-3843-9b9b91e022c416
198377tacrolimus 1 MG Oral CapsulePSN61dee012-43af-0e9a-3843-9b9b91e022c416
198378tacrolimus 5 MG Oral CapsulePSN61dee012-43af-0e9a-3843-9b9b91e022c416
313190tacrolimus 0.5 MG Oral CapsuleSCD61dee012-43af-0e9a-3843-9b9b91e022c416
198377tacrolimus 1 MG Oral CapsuleSCD61dee012-43af-0e9a-3843-9b9b91e022c416
198378tacrolimus 5 MG Oral CapsuleSCD61dee012-43af-0e9a-3843-9b9b91e022c416
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY61dee012-43af-0e9a-3843-9b9b91e022c416
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY61dee012-43af-0e9a-3843-9b9b91e022c416
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY61dee012-43af-0e9a-3843-9b9b91e022c416
313190tacrolimus 0.5 MG Oral CapsulePSN0addf3f5-9bd5-4ef3-8c7f-52be20c16cf96
198378tacrolimus 5 MG Oral CapsulePSN0addf3f5-9bd5-4ef3-8c7f-52be20c16cf96
313190tacrolimus 0.5 MG Oral CapsuleSCD0addf3f5-9bd5-4ef3-8c7f-52be20c16cf96
198378tacrolimus 5 MG Oral CapsuleSCD0addf3f5-9bd5-4ef3-8c7f-52be20c16cf96
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY0addf3f5-9bd5-4ef3-8c7f-52be20c16cf96
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY0addf3f5-9bd5-4ef3-8c7f-52be20c16cf96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-525-01551110525011 BOTTLE in 1 CARTON (55111-525-01) / 100 CAPSULE in 1 BOTTLE1 bottle2010-05-140000-00-00NoNoCurrent
55111-525-05551110525051 BOTTLE in 1 CARTON (55111-525-05) / 500 CAPSULE in 1 BOTTLE1 bottle2010-05-140000-00-00NoNoCurrent
55111-525-30551110525301 BOTTLE in 1 CARTON (55111-525-30) / 30 CAPSULE in 1 BOTTLE1 bottle2010-05-140000-00-00NoNoCurrent
55111-525-785511105257810 BLISTER PACK in 1 CARTON (55111-525-78) / 10 CAPSULE in 1 BLISTER PACK (55111-525-79) 10 blister pack2010-05-140000-00-00NoNoCurrent
55111-525-795511105257910 in 1 BLISTER PACKHistorical