Bexarotene

Product NDC
42291-072
11-digit product format
422910072
Labeler code
42291
Product ID
42291-072_41163fef-69b8-4e09-e063-6294a90ac8ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bexarotene
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA210105
Marketing category
ANDA
Marketing start
2023-04-14
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
42291-072-01Bexarotene100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-072-01EA - Each42291-072723bf37b-968a-4e38-9461-71a93ca4eb1b12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-072BEXAROTENE CAPSULE [AVKARE]1Current NDC, 1 package rows20230415_f9514265-6e2c-9030-e053-6394a90aa04b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
42291-072-0142291007201100 CAPSULE in 1 BOTTLE (42291-072-01) 100 capsule2023-04-14NoNoCurrent