NDC 0378-6612

Amnesteem

Isotretinoin

Amnesteem is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Isotretinoin.

Product ID0378-6612_04880ca3-9af8-45c4-8521-db30e375af47
NDC0378-6612
Product TypeHuman Prescription Drug
Proprietary NameAmnesteem
Generic NameIsotretinoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2002-11-11
Marketing CategoryANDA / ANDA
Application NumberANDA075945
Labeler NameMylan Pharmaceuticals Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength20 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-6612-93

3 BLISTER PACK in 1 CARTON (0378-6612-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6612-85)
Marketing Start Date2002-11-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6612-85 [00378661285]

Amnesteem CAPSULE
Marketing CategoryANDA
Application NumberANDA075945
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-11

NDC 0378-6612-93 [00378661293]

Amnesteem CAPSULE
Marketing CategoryANDA
Application NumberANDA075945
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-11

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN20 mg/1

OpenFDA Data

SPL SET ID:b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 404058
  • 197843
  • 197845
  • 197844
  • 404064
  • 404061
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

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

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

    Trademark Results [Amnesteem]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMNESTEEM
    AMNESTEEM
    78121261 2796119 Live/Registered
    Mylan Bertek Pharmaceuticals Inc.
    2002-04-12

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