Bexarotene

Product NDC
0832-0285
11-digit product format
008320285
Labeler code
0832
Product ID
0832-0285_0392c67b-a83c-4e6c-95d6-09604953652d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bexarotene
Dosage form
CAPSULE
Route
ORAL
Labeler
Upsher-Smith Laboratories, Inc.
Application
ANDA209886
Marketing category
ANDA
Marketing start
2018-07-25
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
0832-0285-00Bexarotene100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0285-00EA - Each0832-02855e292983-ee8e-42d1-8ea8-48c3a9f24e4712018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0285BEXAROTENE CAPSULE [UPSHER-SMITH LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20230415_7437a43f-172a-4f4e-8132-fe23b00224f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308725bexarotene 75 MG Oral CapsulePSN7437a43f-172a-4f4e-8132-fe23b00224f93
308725bexarotene 75 MG Oral CapsuleSCD7437a43f-172a-4f4e-8132-fe23b00224f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0285-0000832028500100 CAPSULE in 1 BOTTLE (0832-0285-00) 100 capsule2018-07-250000-00-00NoNoCurrent