FDA.reportPublic FDA data

Envarsus

Product NDC
68992-3040
11-digit product format
689923040
Labeler code
68992
Product ID
68992-3040_163c129d-f4e2-484d-af96-c265c9a5e38c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Veloxis Pharmaceuticals, Inc
Application
NDA206406
Marketing category
NDA
Marketing start
2015-09-01
Substance
TACROLIMUS
Active strength
4 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
Envarsus
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui1664434, 1664440, 1664456, 1664458, 1664461, 1664463

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68992-3040-1EnvarsusXR1 in 1 POUCHTABLET, EXTENDED RELEASE116
68992-3040-1EnvarsusXR1 in 1 CARTONTABLET, EXTENDED RELEASE116
68992-3040-3EnvarsusXR1 in 1 CARTONTABLET, EXTENDED RELEASE116
68992-3040-3EnvarsusXR1 in 1 POUCHTABLET, EXTENDED RELEASE116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68992-3040ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]16Current NDC, Legacy NDC, 4 package rows20250302_de2315b0-6344-43ac-9aea-3e3b68d828e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1664458Envarsus XR 0.75 MG 24HR Extended Release Oral TabletPSNde2315b0-6344-43ac-9aea-3e3b68d828e716
1664463Envarsus XR 1 MG 24HR Extended Release Oral TabletPSNde2315b0-6344-43ac-9aea-3e3b68d828e716
1664440Envarsus XR 4 MG 24HR Extended Release Oral TabletPSNde2315b0-6344-43ac-9aea-3e3b68d828e716
1664456tacrolimus 0.75 MG 24HR Extended Release Oral TabletPSNde2315b0-6344-43ac-9aea-3e3b68d828e716
1664461tacrolimus 1 MG 24HR Extended Release Oral TabletPSNde2315b0-6344-43ac-9aea-3e3b68d828e716
1664434tacrolimus 4 MG 24HR Extended Release TabletPSNde2315b0-6344-43ac-9aea-3e3b68d828e716
166445824 HR tacrolimus 0.75 MG Extended Release Oral Tablet [Envarsus]SBDde2315b0-6344-43ac-9aea-3e3b68d828e716
166446324 HR tacrolimus 1 MG Extended Release Oral Tablet [Envarsus]SBDde2315b0-6344-43ac-9aea-3e3b68d828e716
166444024 HR tacrolimus 4 MG Extended Release Oral Tablet [Envarsus]SBDde2315b0-6344-43ac-9aea-3e3b68d828e716
166445624 HR tacrolimus 0.75 MG Extended Release Oral TabletSCDde2315b0-6344-43ac-9aea-3e3b68d828e716
166446124 HR tacrolimus 1 MG Extended Release Oral TabletSCDde2315b0-6344-43ac-9aea-3e3b68d828e716
166443424 HR tacrolimus 4 MG Extended Release Oral TabletSCDde2315b0-6344-43ac-9aea-3e3b68d828e716
166445824 HR Envarsus 0.75 MG Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
166446324 HR Envarsus 1 MG Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
166444024 HR Envarsus 4 MG Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
1664458Envarsus XR 0.75 MG 24HR Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
1664463Envarsus XR 1 MG 24HR Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
1664440Envarsus XR 4 MG 24HR Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
1664456tacrolimus 0.75 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
1664461tacrolimus 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716
1664434tacrolimus 4 MG (as anhydrous tacrolimus) 24HR Extended Release TabletSYde2315b0-6344-43ac-9aea-3e3b68d828e716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68992-3040-1689923040011 POUCH in 1 CARTON (68992-3040-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 pouch2015-09-010000-00-00NoNoCurrent
68992-3040-3689923040031 POUCH in 1 CARTON (68992-3040-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC1 pouch2015-09-010000-00-00NoNoCurrent