FDA.reportPublic FDA data

Tacrolimus

Product NDC
16729-041
11-digit product format
167290041
Labeler code
16729
Product ID
16729-041_3622f4f5-48bd-9035-e063-6294a90afac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA091195
Marketing category
ANDA
Marketing start
2011-09-30
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

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
16729-041-01Tacrolimus100 in 1 BOTTLECAPSULE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-041-01EA - Each16729-04112455739-ea45-4df9-be96-ec47a916b77e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
GELATININACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-041TACROLIMUS CAPSULE [ACCORD HEALTHCARE INC.]16Current NDC, Legacy NDC, 1 package rows20250529_bd447ffa-9196-4c3c-accf-5adf29b84665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSNa2e55495-10cc-4f6e-b866-1e7d6e45888b103
313190tacrolimus 0.5 MG Oral CapsuleSCDa2e55495-10cc-4f6e-b866-1e7d6e45888b103
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSYa2e55495-10cc-4f6e-b866-1e7d6e45888b103
2665161tacrolimus 0.5 MG Oral Capsule, BX RatingPSNbd447ffa-9196-4c3c-accf-5adf29b8466516
2665162tacrolimus 1 MG Oral Capsule, BX RatingPSNbd447ffa-9196-4c3c-accf-5adf29b8466516
2665163tacrolimus 5 MG Oral Capsule, BX RatingPSNbd447ffa-9196-4c3c-accf-5adf29b8466516
2665161BX Rating tacrolimus 0.5 MG Oral CapsuleSCDbd447ffa-9196-4c3c-accf-5adf29b8466516
2665162BX Rating tacrolimus 1 MG Oral CapsuleSCDbd447ffa-9196-4c3c-accf-5adf29b8466516
2665163BX Rating tacrolimus 5 MG Oral CapsuleSCDbd447ffa-9196-4c3c-accf-5adf29b8466516
2665161tacrolimus 0.5 MG Oral Capsule, BX RatingSYbd447ffa-9196-4c3c-accf-5adf29b8466516
2665162tacrolimus 1 MG Oral Capsule, BX RatingSYbd447ffa-9196-4c3c-accf-5adf29b8466516
2665163tacrolimus 5 MG Oral Capsule, BX RatingSYbd447ffa-9196-4c3c-accf-5adf29b8466516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-041-0116729004101100 CAPSULE in 1 BOTTLE (16729-041-01) 100 capsule2011-09-300000-00-00NoNoCurrent