NDC 69238-1174

Isotretinoin

Isotretinoin

Isotretinoin is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Isotretinoin.

Product ID69238-1174_03637af3-4595-457a-9da8-c51600d4b338
NDC69238-1174
Product TypeHuman Prescription Drug
Proprietary NameIsotretinoin
Generic NameIsotretinoin
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-10-02
Marketing CategoryANDA / ANDA
Application NumberANDA207792
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NameISOTRETINOIN
Active Ingredient Strength10 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69238-1174-3

3 BLISTER PACK in 1 CARTON (69238-1174-3) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1174-1)
Marketing Start Date2017-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1174-1 [69238117401]

Isotretinoin CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA207792
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-02

NDC 69238-1174-3 [69238117403]

Isotretinoin CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA207792
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-02

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN10 mg/1

OpenFDA Data

SPL SET ID:c2917c3d-3499-48a0-ba53-120cb979195d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197843
  • 403930
  • 197845
  • 197844
  • UPC Code
  • 0369238117431
  • 0369238117417
  • 0369238117639
  • 0369238117530
  • 0369238101737
  • 0369238101713
  • 0369238117516
  • 0369238117615
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

    Medicade Reported Pricing

    69238117403 ISOTRETINOIN 10 MG CAPSULE

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0245-0570IsotretinoinIsotretinoin
    0245-0571IsotretinoinIsotretinoin
    0245-0573IsotretinoinIsotretinoin
    0245-0575IsotretinoinIsotretinoin
    69238-1017IsotretinoinIsotretinoin
    69238-1174IsotretinoinIsotretinoin
    69238-1175IsotretinoinIsotretinoin
    69238-1176IsotretinoinIsotretinoin
    57664-021IsotretinoinIsotretinoin
    57664-023IsotretinoinIsotretinoin
    57664-025IsotretinoinIsotretinoin
    57664-020IsotretinoinIsotretinoin
    57664-022IsotretinoinIsotretinoin
    57664-024IsotretinoinIsotretinoin
    0378-6611Amnesteemisotretinoin
    0378-6612Amnesteemisotretinoin
    0378-6614Amnesteemisotretinoin
    0555-1054ClaravisIsotretinoin
    0555-1055ClaravisIsotretinoin
    0555-1056ClaravisIsotretinoin
    0555-1057ClaravisIsotretinoin

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