Tacrolimus

Product NDC
0904-7097
11-digit product format
009047097
Labeler code
0904
Product ID
0904-7097_0acab888-3921-40c3-a160-b4d7880a812a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090687
Marketing category
ANDA
Marketing start
2014-08-13
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

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
0904-7097-61Tacrolimus100 in 1 CARTONCAPSULE1004
0904-7097-61Tacrolimus1 in 1 BLISTER PACKCAPSULE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7097-61EA - Each0904-7097bf89e79f-eedc-4f2d-8d5a-5de76d2cbb4f12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7097TACROLIMUS CAPSULE [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250209_213f6047-f897-48a7-b78a-45d7124f2f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198377tacrolimus 1 MG Oral CapsulePSN213f6047-f897-48a7-b78a-45d7124f2f164
198377tacrolimus 1 MG Oral CapsuleSCD213f6047-f897-48a7-b78a-45d7124f2f164
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY213f6047-f897-48a7-b78a-45d7124f2f164
198377tacrolimus 1 MG Oral CapsulePSN450c3e32-6d91-4508-b064-49b293e86cec3
198377tacrolimus 1 MG Oral CapsuleSCD450c3e32-6d91-4508-b064-49b293e86cec3
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY450c3e32-6d91-4508-b064-49b293e86cec3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7097-6100904709761100 BLISTER PACK in 1 CARTON (0904-7097-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2014-08-130000-00-00NoNoCurrent