NDC 61748-303

Myorisan

Isotretinoin

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

Product ID61748-303_0617329d-75f1-485d-8800-5b4fab292dd1
NDC61748-303
Product TypeHuman Prescription Drug
Proprietary NameMyorisan
Generic NameIsotretinoin
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA076485
Labeler NameVersaPharm, Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength30 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61748-303-01

5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-303-01)
Marketing Start Date2015-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61748-303-01 [61748030301]

Myorisan CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA076485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-26

NDC 61748-303-11 [61748030311]

Myorisan CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA076485
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-26

NDC 61748-303-13 [61748030313]

Myorisan CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA076485
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-26

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN30 mg/1

OpenFDA Data

SPL SET ID:51ff6346-9256-4c01-9f52-417d13f2df05
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197843
  • 403930
  • 197845
  • 197844
  • 1242615
  • 1242613
  • 1242611
  • 1663728
  • Pharmacological Class

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

    Medicade Reported Pricing

    61748030313 MYORISAN 30 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    61748030311 MYORISAN 30 MG CAPSULE

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    61748-302MyorisanMyorisan
    61748-303MyorisanMyorisan
    61748-304MyorisanMyorisan
    61748-301MyorisanMyorisan
    0378-6611Amnesteemisotretinoin
    0378-6612Amnesteemisotretinoin
    0378-6614Amnesteemisotretinoin
    0555-1054ClaravisIsotretinoin
    0555-1055ClaravisIsotretinoin
    0555-1056ClaravisIsotretinoin
    0555-1057ClaravisIsotretinoin
    0245-0570IsotretinoinIsotretinoin
    0245-0571IsotretinoinIsotretinoin
    0245-0573IsotretinoinIsotretinoin
    0245-0575IsotretinoinIsotretinoin

    Trademark Results [Myorisan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYORISAN
    MYORISAN
    85071559 4199023 Live/Registered
    VERSAPHARM INCORPORATED
    2010-06-25

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