Bexarotene

Product NDC
69238-2088
11-digit product format
692382088
Labeler code
69238
Product ID
69238-2088_e90bb84a-0b45-4163-92da-d8ed239a0b1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bexarotene
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215398
Marketing category
ANDA
Marketing start
2022-05-04
Substance
BEXAROTENE
Active strength
10 mg/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
Bexarotene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEXAROTENE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA61RXM4375
Rxcui308724

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b85274c-8c1c-4060-8314-fc509b5df8c7Product name620250325
ee2ef5df-ff93-4bcb-a381-12cdedb7612cProduct name120230113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2088-6Bexarotene60 g in 1 TUBEGEL607
69238-2088-6Bexarotene1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2088-6GM - Gram69238-2088b695f767-3d17-47af-91e4-f91b85514eb712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2088BEXAROTENE GEL [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 2 package rows20231230_2c21f361-e3d1-45a5-a6e7-df8164e3f90d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308724bexarotene 1 % Topical GelPSN2c21f361-e3d1-45a5-a6e7-df8164e3f90d7
308724bexarotene 0.01 MG/MG Topical GelSCD2c21f361-e3d1-45a5-a6e7-df8164e3f90d7
308724bexarotene 1 % Topical GelSY2c21f361-e3d1-45a5-a6e7-df8164e3f90d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2088-6692382088061 TUBE in 1 CARTON (69238-2088-6) / 60 g in 1 TUBE1 tube2022-05-040000-00-00NoNoCurrent