FDA.reportPublic FDA data

Prograf

Product NDC
0469-0657
11-digit product format
004690657
Labeler code
0469
Product ID
0469-0657_e9157663-1515-4ba3-83b5-1622cf6f0f99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA050708
Marketing category
NDA
Marketing start
1994-04-08
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
Prograf
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui108513, 108514, 108515, 198377, 198378, 198379, 261134, 313190, 2052605, 2052609, 2052703, 2052704

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
0469-0657-11Prograf10 in 1 BLISTER PACKCAPSULE, GELATIN COATED1030
0469-0657-11Prograf10 in 1 CARTONCAPSULE, GELATIN COATED1030
0469-0657-73Prograf100 in 1 BOTTLECAPSULE, GELATIN COATED10030
0469-0657-73Prograf1 in 1 CARTONCAPSULE, GELATIN COATED130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-0657-11EA - Each0469-0657064a80ad-469d-4584-a274-fd9371ae9a9212012-07-24
0469-0657-73EA - Each0469-06570a97ab0d-b6e2-4877-8d5b-01d698933b6e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMPROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]15
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JPROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]15
PEG-60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGPROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-0657PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION PROGRAF (TACROLIMUS) GRANULE, FOR SUSPENSION [ASTELLAS PHARMA US, INC.]30Current NDC, Legacy NDC, 4 package rows20250321_7f667de1-9dfa-4bd6-8ba0-15ee2d78873b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2052609Prograf 0.2 MG Granules for Oral SuspensionPSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
261134Prograf 0.5 MG Oral CapsulePSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052704Prograf 1 MG Granules for Oral SuspensionPSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108513Prograf 1 MG Oral CapsulePSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108515Prograf 5 MG in 1 ML InjectionPSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108514Prograf 5 MG Oral CapsulePSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052605tacrolimus 0.2 MG Granules for Oral SuspensionPSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
313190tacrolimus 0.5 MG Oral CapsulePSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052703tacrolimus 1 MG Granules for Oral SuspensionPSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198377tacrolimus 1 MG Oral CapsulePSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198379tacrolimus 5 MG in 1 ML InjectionPSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198378tacrolimus 5 MG Oral CapsulePSN7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
1085151 ML tacrolimus 5 MG/ML Injection [Prograf]SBD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052609tacrolimus 0.2 MG Granules for Oral Suspension [Prograf]SBD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
261134tacrolimus 0.5 MG Oral Capsule [Prograf]SBD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052704tacrolimus 1 MG Granules for Oral Suspension [Prograf]SBD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108513tacrolimus 1 MG Oral Capsule [Prograf]SBD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108514tacrolimus 5 MG Oral Capsule [Prograf]SBD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
1983791 ML tacrolimus 5 MG/ML InjectionSCD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052605tacrolimus 0.2 MG Granules for Oral SuspensionSCD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
313190tacrolimus 0.5 MG Oral CapsuleSCD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052703tacrolimus 1 MG Granules for Oral SuspensionSCD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198377tacrolimus 1 MG Oral CapsuleSCD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198378tacrolimus 5 MG Oral CapsuleSCD7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052609Prograf 0.2 MG Granules for Oral SuspensionSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
261134Prograf 0.5 MG Oral CapsuleSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
2052704Prograf 1 MG Granules for Oral SuspensionSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108513Prograf 1 MG Oral CapsuleSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108514Prograf 5 MG Oral CapsuleSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
108515Prograf 5 MG per 1 ML InjectionSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30
198379tacrolimus 5 MG per 1 ML InjectionSY7f667de1-9dfa-4bd6-8ba0-15ee2d78873b30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0469-0657-110046906571110 BLISTER PACK in 1 CARTON (0469-0657-11) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK10 blister pack1994-04-080000-00-00NoNoCurrent
0469-0657-73004690657731 BOTTLE in 1 CARTON (0469-0657-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle1994-04-080000-00-00NoNoCurrent