Bexarotene

Product NDC
31722-380
11-digit product format
317220380
Labeler code
31722
Product ID
31722-380_fbea212d-1296-43aa-bae6-9f2b56020b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bexarotene
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA208628
Marketing category
ANDA
Marketing start
2025-05-21
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
31722-380-01Bexarotene1 in 1 CARTONCAPSULE11
31722-380-01Bexarotene100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-380-01EA - Each31722-38062e50524-b86a-44ca-b266-f6b2884cf1ef12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308725bexarotene 75 MG Oral CapsulePSN374c42b1-3d7f-4ca3-9d3a-2a111286f7ca1
308725bexarotene 75 MG Oral CapsuleSCD374c42b1-3d7f-4ca3-9d3a-2a111286f7ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-380-01317220380011 BOTTLE in 1 CARTON (31722-380-01) / 100 CAPSULE in 1 BOTTLE1 bottle2025-05-21NoNoCurrent