NDC 55111-136

ZENATANE

Isotretinoin

ZENATANE is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Isotretinoin.

Product ID55111-136_1f5178c1-0f6f-824d-d0ee-1b973377ccc6
NDC55111-136
Product TypeHuman Prescription Drug
Proprietary NameZENATANE
Generic NameIsotretinoin
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2013-03-26
Marketing CategoryANDA / ANDA
Application NumberANDA202099
Labeler NameDr. Reddy's Laboratories Limited
Substance NameISOTRETINOIN
Active Ingredient Strength20 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55111-136-81

3 BLISTER PACK in 1 CARTON (55111-136-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-136-79)
Marketing Start Date2013-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55111-136-81 [55111013681]

ZENATANE CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA202099
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-26

NDC 55111-136-79 [55111013679]

ZENATANE CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA202099
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-26

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN20 mg/1

OpenFDA Data

SPL SET ID:27b3cf26-f22e-5b70-1c24-009933b7c6ee
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197843
  • 403930
  • 197845
  • 197844
  • 1373337
  • 1373335
  • 1373333
  • 1605088
  • Pharmacological Class

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

    Medicade Reported Pricing

    55111013681 ZENATANE 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    55111013679 ZENATANE 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    55111-135ZENATANEZENATANE
    55111-136ZENATANEZENATANE
    55111-137ZENATANEZENATANE
    55111-113ZENATANEZENATANE
    0378-6611Amnesteemisotretinoin
    0378-6612Amnesteemisotretinoin
    0378-6614Amnesteemisotretinoin
    0555-1054ClaravisIsotretinoin
    0555-1055ClaravisIsotretinoin
    0555-1056ClaravisIsotretinoin
    0555-1057ClaravisIsotretinoin
    0245-0570IsotretinoinIsotretinoin
    0245-0571IsotretinoinIsotretinoin
    0245-0573IsotretinoinIsotretinoin
    0245-0575IsotretinoinIsotretinoin

    Trademark Results [ZENATANE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZENATANE
    ZENATANE
    85472712 4358712 Live/Registered
    Promius Pharma, LLC
    2011-11-15

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