FDA.reportPublic FDA data

Tacrolimus

Product NDC
82804-032
11-digit product format
828040032
Labeler code
82804
Product ID
82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065461
Marketing category
ANDA
Marketing start
2009-08-10
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
82804-032-30Tacrolimus30 in 1 BOTTLECAPSULE301
82804-032-60Tacrolimus60 in 1 BOTTLECAPSULE601
82804-032-90Tacrolimus90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-032-30EA - Each82804-032d1f04c33-74ff-44b0-a5ad-165210c2ef3c12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-032TACROLIMUS CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20231027_20d1c12a-bf4b-4467-93a0-ee8b892abea9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198377tacrolimus 1 MG Oral CapsulePSN20d1c12a-bf4b-4467-93a0-ee8b892abea91
198377tacrolimus 1 MG Oral CapsuleSCD20d1c12a-bf4b-4467-93a0-ee8b892abea91
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY20d1c12a-bf4b-4467-93a0-ee8b892abea91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-032-308280400323030 CAPSULE in 1 BOTTLE (82804-032-30) 30 capsule2023-10-25NoNoCurrent
82804-032-608280400326060 CAPSULE in 1 BOTTLE (82804-032-60) 60 capsule2023-10-25NoNoCurrent
82804-032-908280400329090 CAPSULE in 1 BOTTLE (82804-032-90) 90 capsule2023-10-25NoNoCurrent