FDA.reportPublic FDA data

Tacrolimus

Product NDC
68462-881
11-digit product format
684620881
Labeler code
68462
Product ID
68462-881_15dcd504-ee3e-4f0f-a765-55e31511641e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210393
Marketing category
ANDA
Marketing start
2023-08-16
Substance
TACROLIMUS
Active strength
.3 mg/g
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
Tacrolimus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS.3 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWM0HAQ4WNM
Rxcui313189, 314266

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
68462-881-35Tacrolimus1 in 1 CARTONOINTMENT18
68462-881-35Tacrolimus30 g in 1 TUBEOINTMENT308
68462-881-65Tacrolimus60 g in 1 TUBEOINTMENT608
68462-881-65Tacrolimus1 in 1 CARTONOINTMENT18
68462-881-94Tacrolimus100 g in 1 TUBEOINTMENT1008
68462-881-94Tacrolimus1 in 1 CARTONOINTMENT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-881-35GM - Gram68462-88146cb57a3-21b6-4394-a7ae-829fa4d0319a12023-09-05
68462-881-65GM - Gram68462-88164b8bf0a-0212-4217-9686-5104c844a48c12023-09-05
68462-881-94GM - Gram68462-881e8d5e6b6-3e7c-4c67-9f49-4f7a69d45c7212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-881TACROLIMUS OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, 6 package rows20230822_c2d2e3a1-f346-4245-b445-6dd44e371180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313189tacrolimus 0.03 % Topical OintmentPSNc2d2e3a1-f346-4245-b445-6dd44e3711808
314266tacrolimus 0.1 % Topical OintmentPSNc2d2e3a1-f346-4245-b445-6dd44e3711808
313189tacrolimus 0.0003 MG/MG Topical OintmentSCDc2d2e3a1-f346-4245-b445-6dd44e3711808
314266tacrolimus 0.001 MG/MG Topical OintmentSCDc2d2e3a1-f346-4245-b445-6dd44e3711808
313189tacrolimus (as tacrolimus monohydrate) 0.0003 MG/MG Topical OintmentSYc2d2e3a1-f346-4245-b445-6dd44e3711808
314266tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical OintmentSYc2d2e3a1-f346-4245-b445-6dd44e3711808
313189tacrolimus 0.03 % Topical OintmentSYc2d2e3a1-f346-4245-b445-6dd44e3711808
314266tacrolimus 0.1 % Topical OintmentSYc2d2e3a1-f346-4245-b445-6dd44e3711808

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-881-35684620881351 TUBE in 1 CARTON (68462-881-35) / 30 g in 1 TUBE1 tube2023-08-16NoNoCurrent
68462-881-65684620881651 TUBE in 1 CARTON (68462-881-65) / 60 g in 1 TUBE1 tube2023-08-16NoNoCurrent
68462-881-94684620881941 TUBE in 1 CARTON (68462-881-94) / 100 g in 1 TUBE1 tube2023-08-16NoNoCurrent