FDA.reportPublic FDA data

Tacrolimus

Product NDC
21922-011
11-digit product format
219220011
Labeler code
21922
Product ID
21922-011_9197a805-bb44-44b8-9ae7-d39a01acb1a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus Ointment 0.1%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA212387
Marketing category
ANDA
Marketing start
2023-10-13
Substance
TACROLIMUS
Active strength
1 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui314266

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
21922-011-05Tacrolimus30 g in 1 TUBEOINTMENT304
21922-011-05Tacrolimus1 in 1 CARTONOINTMENT14
21922-011-07Tacrolimus1 in 1 CARTONOINTMENT14
21922-011-07Tacrolimus60 g in 1 TUBEOINTMENT604
21922-011-09Tacrolimus1 in 1 CARTONOINTMENT14
21922-011-09Tacrolimus100 g in 1 TUBEOINTMENT1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-011-05GM - Gram21922-0110cf3d86a-7df1-44df-befa-b7ccdaa1a95412024-02-14
21922-011-07GM - Gram21922-011ea4653fc-3d4c-45ab-a14b-a67a74bf8de812024-02-14
21922-011-09GM - Gram21922-011dcbc5fcb-4138-420f-a249-90aa5e01551e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-011TACROLIMUS (TACROLIMUS OINTMENT 0.1%) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]3Current NDC, 6 package rows20231016_43b38551-6c5e-48a4-a453-9286f1c16b34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314266tacrolimus 0.1 % Topical OintmentPSN43b38551-6c5e-48a4-a453-9286f1c16b344
314266tacrolimus 0.001 MG/MG Topical OintmentSCD43b38551-6c5e-48a4-a453-9286f1c16b344
314266tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical OintmentSY43b38551-6c5e-48a4-a453-9286f1c16b344
314266tacrolimus 0.1 % Topical OintmentSY43b38551-6c5e-48a4-a453-9286f1c16b344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-011-05219220011051 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE1 tube2023-10-13NoNoCurrent
21922-011-07219220011071 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE1 tube2023-10-13NoNoCurrent
21922-011-09219220011091 TUBE in 1 CARTON (21922-011-09) / 100 g in 1 TUBE1 tube2023-10-13NoNoCurrent