FDA.reportPublic FDA data

Tacrolimus

Product NDC
0168-0416
11-digit product format
001680416
Labeler code
0168
Product ID
0168-0416_a63cc4f4-5aba-4e02-915a-5535f2b625aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA200744
Marketing category
ANDA
Marketing start
2014-09-09
Substance
TACROLIMUS
Active strength
1 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
TACROLIMUS1 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0416-302020-09-10C16284748780-1ab0e2407-347c-f274-e053-dbdaa90a6471TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1%
0168-0416-602020-09-10C16284748780-1ab0e2407-347c-f274-e053-dbdaa90a6471TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1%
0168-0416-992020-09-10C16284748780-1ab0e2407-347c-f274-e053-dbdaa90a6471TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1%
0168-0416-302020-07-22C16284748780-1ab0e2407-347c-f274-e053-dbdaa90a6471TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1%
0168-0416-602020-07-22C16284748780-1ab0e2407-347c-f274-e053-dbdaa90a6471TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1%
0168-0416-992020-07-22C16284748780-1ab0e2407-347c-f274-e053-dbdaa90a6471TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0416-30Tacrolimus30 g in 1 TUBEOINTMENT3013
0168-0416-30Tacrolimus1 in 1 CARTONOINTMENT113
0168-0416-60Tacrolimus1 in 1 CARTONOINTMENT113
0168-0416-60Tacrolimus60 g in 1 TUBEOINTMENT6013
0168-0416-99Tacrolimus100 g in 1 TUBEOINTMENT10013
0168-0416-99Tacrolimus1 in 1 CARTONOINTMENT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0416-30GM - Gram0168-04161c211141-e4e9-4175-a6f2-210218ae5f1812014-12-01
0168-0416-60GM - Gram0168-041670d27d54-2dee-4add-92e0-e470b9e74daa12014-12-01
0168-0416-99GM - Gram0168-0416b465c9f6-529b-45d2-89e4-1c3fd54ab4bb12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tacrolimusACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
mineral oilINACTIVE INGREDIENTT5L8T28FGPTACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
paraffinINACTIVE INGREDIENTI9O0E3H2ZETACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
petrolatumINACTIVE INGREDIENT4T6H12BN9UTACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
propylene carbonateINACTIVE INGREDIENT8D08K3S51ETACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
white waxINACTIVE INGREDIENT7G1J5DA97FTACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0416TACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 6 package rows20231102_1bf44a84-14fd-4f80-ad8a-99b1431d631f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313189tacrolimus 0.03 % Topical OintmentPSN1bf44a84-14fd-4f80-ad8a-99b1431d631f13
314266tacrolimus 0.1 % Topical OintmentPSN1bf44a84-14fd-4f80-ad8a-99b1431d631f13
313189tacrolimus 0.0003 MG/MG Topical OintmentSCD1bf44a84-14fd-4f80-ad8a-99b1431d631f13
314266tacrolimus 0.001 MG/MG Topical OintmentSCD1bf44a84-14fd-4f80-ad8a-99b1431d631f13
313189tacrolimus (as tacrolimus monohydrate) 0.0003 MG/MG Topical OintmentSY1bf44a84-14fd-4f80-ad8a-99b1431d631f13
314266tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical OintmentSY1bf44a84-14fd-4f80-ad8a-99b1431d631f13
313189tacrolimus 0.03 % Topical OintmentSY1bf44a84-14fd-4f80-ad8a-99b1431d631f13
314266tacrolimus 0.1 % Topical OintmentSY1bf44a84-14fd-4f80-ad8a-99b1431d631f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0416-30001680416301 TUBE in 1 CARTON (0168-0416-30) / 30 g in 1 TUBE1 tube2014-09-090000-00-00NoNoCurrent
0168-0416-60001680416601 TUBE in 1 CARTON (0168-0416-60) / 60 g in 1 TUBE1 tube2014-09-090000-00-00NoNoCurrent
0168-0416-99001680416991 TUBE in 1 CARTON (0168-0416-99) / 100 g in 1 TUBE1 tube2014-09-090000-00-00NoNoCurrent