NDC 0145-0090

SORIATANE

Acitretin

SORIATANE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Stiefel Laboratories Inc. The primary component is Acitretin.

Product ID0145-0090_362d9712-c25c-4ae3-9fba-358bc02d5062
NDC0145-0090
Product TypeHuman Prescription Drug
Proprietary NameSORIATANE
Generic NameAcitretin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1996-11-01
Marketing CategoryNDA / NDA
Application NumberNDA019821
Labeler NameStiefel Laboratories Inc
Substance NameACITRETIN
Active Ingredient Strength10 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0145-0090-25

30 CAPSULE in 1 BOTTLE (0145-0090-25)
Marketing Start Date1996-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0145-0090-25 [00145009025]

SORIATANE CAPSULE
Marketing CategoryNDA
Application NumberNDA019821
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-11-01

Drug Details

Active Ingredients

IngredientStrength
ACITRETIN10 mg/1

OpenFDA Data

SPL SET ID:cec7851f-c7af-4e9e-a5e4-a585c70510d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199689
  • 213070
  • 199690
  • 213069
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

    NDC Crossover Matching brand name "SORIATANE" or generic name "Acitretin"

    NDCBrand NameGeneric Name
    0145-0090SORIATANEacitretin
    0145-0091SORIATANEacitretin
    0093-1135AcitretinAcitretin
    0093-1136AcitretinAcitretin
    0093-1138AcitretinAcitretin
    0115-1667AcitretinAcitretin
    0115-1668AcitretinAcitretin
    0115-1669AcitretinAcitretin
    0115-1698AcitretinAcitretin
    0115-1750AcitretinAcitretin
    0115-1751AcitretinAcitretin
    0115-1752AcitretinAcitretin
    0115-1753AcitretinAcitretin

    Trademark Results [SORIATANE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SORIATANE
    SORIATANE
    73686706 1497384 Live/Registered
    HOFFMANN-LA ROCHE INC.
    1987-09-28

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