AKLIEF

Product NDC
0299-5935
11-digit product format
002995935
Labeler code
0299
Product ID
0299-5935_21db90dd-c7e5-79d1-e063-6294a90ab57e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trifarotene
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA211527
Marketing category
NDA
Marketing start
2019-10-04
Substance
TRIFAROTENE
Active strength
50 ug/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AKLIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFAROTENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J8RN2W0HK
Rxcui2205642, 2205647

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
93d3fa60-cf67-45a9-92a6-36026d03ab27Product name120200304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-5935-02AKLIEF2 g in 1 TUBECREAM27
0299-5935-02AKLIEF1 in 1 BLISTER PACKCREAM17
0299-5935-30AKLIEF30 g in 1 BOTTLE, PUMPCREAM307
0299-5935-30AKLIEF1 in 1 CARTONCREAM17
0299-5935-45AKLIEF45 g in 1 BOTTLE, PUMPCREAM457
0299-5935-45AKLIEF1 in 1 CARTONCREAM17
0299-5935-75AKLIEF75 g in 1 BOTTLE, PUMPCREAM757
0299-5935-75AKLIEF1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5935-45GM - Gram0299-5935ce1a0c2a-a850-4965-bd2b-79c19b0e6fbf12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5935AKLIEF (TRIFAROTENE) CREAM [GALDERMA LABORATORIES, L.P.]7Current NDC, Legacy NDC, 8 package rows20240918_62d910db-85a6-4696-b69b-4bd2f3080cfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2205647AKLIEF 0.005 % Topical CreamPSN62d910db-85a6-4696-b69b-4bd2f3080cfc7
2205642trifarotene 0.005 % Topical CreamPSN62d910db-85a6-4696-b69b-4bd2f3080cfc7
2205647trifarotene 0.05 MG/ML Topical Cream [Aklief]SBD62d910db-85a6-4696-b69b-4bd2f3080cfc7
2205642trifarotene 0.05 MG/ML Topical CreamSCD62d910db-85a6-4696-b69b-4bd2f3080cfc7
2205647Aklief 0.005 % Topical CreamSY62d910db-85a6-4696-b69b-4bd2f3080cfc7
2205647Aklief 0.05 MG/ML Topical CreamSY62d910db-85a6-4696-b69b-4bd2f3080cfc7
2205642trifarotene 0.005 % Topical CreamSY62d910db-85a6-4696-b69b-4bd2f3080cfc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5935-02002995935021 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE1 tube2019-10-040000-00-00YesNoCurrent
0299-5935-30002995935301 BOTTLE, PUMP in 1 CARTON (0299-5935-30) > 30 g in 1 BOTTLE, PUMP2019-10-040000-00-00NoNoCurrent
0299-5935-45002995935451 BOTTLE, PUMP in 1 CARTON (0299-5935-45) / 45 g in 1 BOTTLE, PUMP2019-10-040000-00-00NoNoCurrent
0299-5935-75002995935751 BOTTLE, PUMP in 1 CARTON (0299-5935-75) > 75 g in 1 BOTTLE, PUMP2019-10-040000-00-00NoNoCurrent