Bexarotene

Product NDC
69238-1250
11-digit product format
692381250
Labeler code
69238
Product ID
69238-1250_9e70a6ae-538e-406a-9814-a0a21121ba3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bexarotene
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210105
Marketing category
ANDA
Marketing start
2018-09-04
Substance
BEXAROTENE
Active strength
75 mg/1
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
BEXAROTENE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA61RXM4375
Rxcui308725

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
69238-1250-1Bexarotene100 in 1 BOTTLECAPSULE10012
69238-1250-1Bexarotene1 in 1 CARTONCAPSULE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1250-1EA - Each69238-12509129a82b-23c3-454b-aa94-a3399bc1038d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1250BEXAROTENE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 2 package rows20230608_d7fc7c7b-2ecf-4543-8bb4-9b4415d66613.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308725bexarotene 75 MG Oral CapsulePSNd7fc7c7b-2ecf-4543-8bb4-9b4415d6661312
308725bexarotene 75 MG Oral CapsuleSCDd7fc7c7b-2ecf-4543-8bb4-9b4415d6661312
308725bexarotene 75 MG Oral CapsulePSNf9514265-6e2c-9030-e053-6394a90aa04b2
308725bexarotene 75 MG Oral CapsuleSCDf9514265-6e2c-9030-e053-6394a90aa04b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1250-1692381250011 BOTTLE in 1 CARTON (69238-1250-1) / 100 CAPSULE in 1 BOTTLE1 bottle2018-09-040000-00-00NoNoCurrent