NDC 42292-007

Bexarotene

Bexarotene

Bexarotene is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Bexarotene.

Product ID42292-007_7cef9597-58f6-339f-e053-2991aa0a1efb
NDC42292-007
Product TypeHuman Prescription Drug
Proprietary NameBexarotene
Generic NameBexarotene
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA203174
Labeler NameMylan Institutional Inc.
Substance NameBEXAROTENE
Active Ingredient Strength75 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42292-007-10

10 BLISTER PACK in 1 CARTON (42292-007-10) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (42292-007-01)
Marketing Start Date2016-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42292-007-10 [42292000710]

Bexarotene CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA203174
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-15
Marketing End Date2020-01-31

NDC 42292-007-01 [42292000701]

Bexarotene CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA203174
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-15
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BEXAROTENE75 mg/1

OpenFDA Data

SPL SET ID:9410215d-828c-454c-a44e-ad0fb0c65f68
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308725
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

    NDC Crossover Matching brand name "Bexarotene" or generic name "Bexarotene"

    NDCBrand NameGeneric Name
    0054-0399Bexarotenebexarotene
    0378-6955BexaroteneBexarotene
    0591-2832bexarotenebexarotene
    0832-0285BexaroteneBexarotene
    42292-007BexaroteneBexarotene
    43975-315BexaroteneBexarotene
    68682-002bexarotenebexarotene
    68682-003bexarotenebexarotene
    69238-1250BexaroteneBexarotene
    69238-2088BexaroteneBexarotene
    0187-5525Targretinbexarotene
    0187-5526Targretinbexarotene

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