Bexarotene

Product NDC
43975-315
11-digit product format
439750315
Labeler code
43975
Product ID
43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bexarotene
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA209861
Marketing category
ANDA
Marketing start
2018-05-10
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
43975-315-10Bexarotene100 in 1 BOTTLECAPSULE, LIQUID FILLED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43975-315-10EA - Each43975-315d4752bf5-15d0-4701-8750-9d534236fbd412018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43975-315BEXAROTENE CAPSULE, LIQUID FILLED [ANI PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20241129_e713c60d-f623-4260-b0ca-db07e1365fd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308725bexarotene 75 MG Oral CapsulePSNe713c60d-f623-4260-b0ca-db07e1365fd28
308725bexarotene 75 MG Oral CapsuleSCDe713c60d-f623-4260-b0ca-db07e1365fd28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43975-315-1043975031510100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10) 2018-05-100000-00-00NoNoCurrent