FDA.reportPublic FDA data

tacrolimus

Product NDC
68462-686
11-digit product format
684620686
Labeler code
68462
Product ID
68462-686_13e3f94c-d4c5-4b5b-a51a-0e87eadc5718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA206662
Marketing category
ANDA
Marketing start
2020-11-10
Substance
TACROLIMUS
Active strength
1 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
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
68462-686-01tacrolimus100 in 1 BOTTLECAPSULE1006
68462-686-14tacrolimus10 in 1 CARTONCAPSULE106
68462-686-14tacrolimus10 in 1 BLISTER PACKCAPSULE106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-686-01EA - Each68462-68690f4ce3d-d13d-4be6-8855-da0a1440c8c812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-686TACROLIMUS CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 3 package rows20231020_4b310c6b-e035-4e44-9573-4001d58b2ad5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313190tacrolimus 0.5 MG Oral CapsulePSN4b310c6b-e035-4e44-9573-4001d58b2ad56
198377tacrolimus 1 MG Oral CapsulePSN4b310c6b-e035-4e44-9573-4001d58b2ad56
198378tacrolimus 5 MG Oral CapsulePSN4b310c6b-e035-4e44-9573-4001d58b2ad56
313190tacrolimus 0.5 MG Oral CapsuleSCD4b310c6b-e035-4e44-9573-4001d58b2ad56
198377tacrolimus 1 MG Oral CapsuleSCD4b310c6b-e035-4e44-9573-4001d58b2ad56
198378tacrolimus 5 MG Oral CapsuleSCD4b310c6b-e035-4e44-9573-4001d58b2ad56
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY4b310c6b-e035-4e44-9573-4001d58b2ad56
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY4b310c6b-e035-4e44-9573-4001d58b2ad56
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY4b310c6b-e035-4e44-9573-4001d58b2ad56
198377tacrolimus 1 MG Oral CapsulePSN3519febc-c9df-4559-b07a-92f8b0c7e7703
198377tacrolimus 1 MG Oral CapsuleSCD3519febc-c9df-4559-b07a-92f8b0c7e7703
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY3519febc-c9df-4559-b07a-92f8b0c7e7703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-686-0168462068601100 CAPSULE in 1 BOTTLE (68462-686-01) 100 capsule2020-11-100000-00-00NoNoCurrent
68462-686-146846206861410 BLISTER PACK in 1 CARTON (68462-686-14) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2020-11-100000-00-00NoNoCurrent