FDA.reportPublic FDA data

Tacrolimus

Product NDC
64380-722
11-digit product format
643800722
Labeler code
64380
Product ID
64380-722_d4a7fb82-5ff6-4ffc-bec5-ff0d50347a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA090687
Marketing category
ANDA
Marketing start
2020-10-05
Substance
TACROLIMUS
Active strength
5 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tacrolimus
Listing expiration
2027-12-31

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
64380-722-01Tacrolimus10 in 1 CARTONCAPSULE1019
64380-722-01Tacrolimus10 in 1 BLISTER PACKCAPSULE1019
64380-722-06Tacrolimus100 in 1 CONTAINERCAPSULE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-722-06EA - Each64380-7223235c037-ef92-4360-a9b3-239a620d167112014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
GELATININACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [STRIDES ARCOLAB LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-722TACROLIMUS CAPSULE [STRIDES PHARMA SCIENCE LIMITED]18Current NDC, Legacy NDC, 3 package rows20231121_ed7d1495-3585-409d-94f1-b3d2469d222c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSNed7d1495-3585-409d-94f1-b3d2469d222c19
198377tacrolimus 1 MG Oral CapsulePSNed7d1495-3585-409d-94f1-b3d2469d222c19
198378tacrolimus 5 MG Oral CapsulePSNed7d1495-3585-409d-94f1-b3d2469d222c19
313190tacrolimus 0.5 MG Oral CapsuleSCDed7d1495-3585-409d-94f1-b3d2469d222c19
198377tacrolimus 1 MG Oral CapsuleSCDed7d1495-3585-409d-94f1-b3d2469d222c19
198378tacrolimus 5 MG Oral CapsuleSCDed7d1495-3585-409d-94f1-b3d2469d222c19
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSYed7d1495-3585-409d-94f1-b3d2469d222c19
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSYed7d1495-3585-409d-94f1-b3d2469d222c19
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSYed7d1495-3585-409d-94f1-b3d2469d222c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-722-016438007220110 BLISTER PACK in 1 CARTON (64380-722-01) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2020-10-050000-00-00NoNoCurrent
64380-722-0664380072206100 CAPSULE in 1 CONTAINER (64380-722-06) 100 capsule2020-10-050000-00-00NoNoCurrent