FDA.reportPublic FDA data

ASTAGRAF XL

Product NDC
0469-0677
11-digit product format
004690677
Labeler code
0469
Product ID
0469-0677_4ecfe626-bf9c-4889-a1d4-64b03d60eaf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus extended-release capsules
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA204096
Marketing category
NDA
Marketing start
2013-07-19
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
ASTAGRAF XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui1431971, 1431977, 1431980, 1431982, 1431985, 1431987

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
0469-0677-11ASTAGRAF XL10 in 1 BLISTER PACKCAPSULE, COATED, EXTENDED RELEAS1012
0469-0677-11ASTAGRAF XL5 in 1 CARTONCAPSULE, COATED, EXTENDED RELEAS512
0469-0677-73ASTAGRAF XL1 in 1 CARTONCAPSULE, COATED, EXTENDED RELEAS112
0469-0677-73ASTAGRAF XL30 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-0677-73EA - Each0469-0677b43960a0-2e3c-42f3-8655-2528d75115c112013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]4
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-0677ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]11Current NDC, Legacy NDC, 4 package rows20230927_550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431977Astagraf XL 0.5 MG 24HR Extended Release Oral CapsulePSN550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431982Astagraf XL 1 MG 24HR Extended Release Oral CapsulePSN550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431987Astagraf XL 5 MG 24HR Extended Release Oral CapsulePSN550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431971tacrolimus 0.5 MG 24HR Extended Release Oral CapsulePSN550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431980tacrolimus 1 MG 24HR Extended Release Oral CapsulePSN550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431985tacrolimus 5 MG 24HR Extended Release Oral CapsulePSN550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143197724 HR tacrolimus 0.5 MG Extended Release Oral Capsule [Astagraf]SBD550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143198224 HR tacrolimus 1 MG Extended Release Oral Capsule [Astagraf]SBD550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143198724 HR tacrolimus 5 MG Extended Release Oral Capsule [Astagraf]SBD550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143197124 HR tacrolimus 0.5 MG Extended Release Oral CapsuleSCD550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143198024 HR tacrolimus 1 MG Extended Release Oral CapsuleSCD550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143198524 HR tacrolimus 5 MG Extended Release Oral CapsuleSCD550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143197724 HR Astagraf 0.5 MG Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143198224 HR Astagraf 1 MG Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
143198724 HR Astagraf 5 MG Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431977Astagraf XL 0.5 MG 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431982Astagraf XL 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431982Astagraf XL 1 MG 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431987Astagraf XL 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431987Astagraf XL 5 MG 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431971tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431980tacrolimus 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12
1431985tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0469-0677-11004690677115 BLISTER PACK in 1 CARTON (0469-0677-11) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2013-07-190000-00-00NoNoCurrent
0469-0677-73004690677731 BOTTLE in 1 CARTON (0469-0677-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2013-07-190000-00-00NoNoCurrent