NDC 0555-1054

Claravis

Isotretinoin

Claravis is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Isotretinoin.

Product ID0555-1054_10276cf5-9f65-4a32-8b0d-201fa5b2bc20
NDC0555-1054
Product TypeHuman Prescription Drug
Proprietary NameClaravis
Generic NameIsotretinoin
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2003-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA076356
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength10 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0555-1054-56

10 BLISTER PACK in 1 CARTON (0555-1054-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)
Marketing Start Date2003-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0555-1054-56 [00555105456]

Claravis CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA076356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-05-09

NDC 0555-1054-86 [00555105486]

Claravis CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA076356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-05-09

NDC 0555-1054-60 [00555105460]

Claravis CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA076356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-05

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN10 mg/1

OpenFDA Data

SPL SET ID:a31fd109-d0fd-4ab9-ba98-a3d64333c18d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 404059
  • 197843
  • 403930
  • 197845
  • 197844
  • 404065
  • 404062
  • 643488
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]
    • Retinoid [EPC]
    • Retinoids [CS]

    NDC Crossover Matching brand name "Claravis" or generic name "Isotretinoin"

    NDCBrand NameGeneric Name
    0555-1054ClaravisIsotretinoin
    0555-1055ClaravisIsotretinoin
    0555-1056ClaravisIsotretinoin
    0555-1057ClaravisIsotretinoin
    0378-6611Amnesteemisotretinoin
    0378-6612Amnesteemisotretinoin
    0378-6614Amnesteemisotretinoin
    0245-0570IsotretinoinIsotretinoin
    0245-0571IsotretinoinIsotretinoin
    0245-0573IsotretinoinIsotretinoin
    0245-0575IsotretinoinIsotretinoin

    Trademark Results [Claravis]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLARAVIS
    CLARAVIS
    97432561 not registered Live/Pending
    BARR Laboratories, Inc.
    2022-05-27
    CLARAVIS
    CLARAVIS
    76503621 not registered Dead/Abandoned
    Barr Laboratories, Inc.
    2003-04-03

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